FDA News and Announcements

GXPNews - FDA News & Announcements December 2 - December 13, 2024

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Whats New with CDER
Drug News and Events

December 13, 2024

Orange Book
- Approved Drug Products with Therapeutic Equivalence Evaluations
- Orange Book Current Cumulative Supplement (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
- Orange Book Data Files (compressed) (updated)
- Reference Listed Drugs by ANDA Reference Standard List (updated)
- Orange Book Patent Listing Dispute List (updated)

December 12, 2024

CDER establishes new Center for Real-World Evidence Innovation
FDA Drug Safety Communication: Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitis

December 9, 2024

FDA Drug Topics: An Update onTransmucosal Buprenorphine and Dental Caries - December 10, 2024 at 1pm ET

December 6, 2024

December 5, 2024

December 4, 2024

December 3, 2024

Patent Certifications and Suitability Petitions (updated)

November 27, 2024

CDER Meetings and Conferences

04/09/2025	Generic Drugs Forum (GDF) 2025
03/25/2025	GMP QMS FREE 8-hour Training Hosted by The Auditing Group
02/19/2025	GMP QMS FREE 8-hour Training Hosted by The Auditing Group
02/05/2025	February 5, 2025: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
01/28/2025	Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA
01/22/2025	BsUFA III Regulatory Science Pilot Program: Progress Update
01/10/2025	January 10, 2025: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
01/07/2025	GMP QMS FREE 8-hour Training Hosted by The Auditing Group

Dietary Supplements

Featured Links

Applications & Submissions

Related Resources

Whats New with CDRH
Medical Device News and Events

December 11, 2024

Consumer Information: nAbCyte Anti-AAVRh74var HB-FE Assay - H230005 (LabCorp Drug Development)
Early Alert: Infusion Pump Issue from Fresenius Kabi USA
2024 Medical Device Recalls (Updated)
Federal Register: Emergency Use Authorization: B. Braun Medical's Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES; Revocation

December 10, 2024

De Novo Decision Summaries (Updated):
- DEN220047 - Galen ES Cooperative Surgical Assistant Platform, Galen ES
- DEN220052 - BrachyGel Vaginal Hydrogel Packing System
MedSun Newsletter - December 2024

December 9, 2024

Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems - Letter to Health Care Providers (Updated)
OSEL Summer Research Program (Updated: 2025 Summer Program now open)

December 6, 2024

December 5, 2024

Reports on Non-Device Software Functions
- 2024 Report on Non-Device Software Functions (PDF - 1.72 MB)
Revised Emergency Use Authorizations
- Quest Diagnostics Mpox Virus Qualitative Real-Time PCR (2-well) (Quest Diagnostics Nichols Institute)

December 4, 2024

Class I Recall: Syringe Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to Incompatibility with Needleless Connectors
Medical Device Shortages List (Updated)
Consumer Information: Esprit BTK Everolimus Eluting Resorbable Scaffold System - P230036 (Abbott Medical)

December 3, 2024

De Novo Decision Summaries (Updated):
- DEN230061 - Allay Nerve Cap
- DEN230078 - Versius Surgical System
- DEN230068 - 3MTM ATTESTTM EBowie-Dick Test
- DEN230076 - Omron Blood Pressure Monitor with AFIB Detection Feature
- DEN220042 - Terragene Bionova Photon Biological Indicator & Auto Reader Incubator (BPH)
De Novo Classification Order:
- DEN230085 - VERIFYTM RESI-TESTTM SLIDE-THRU Cleaning Process Protein (CPP) Indicator
- DEN240023 - SmartFlow Neuro Cannula
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions - Guidance for Industry and Food and Drug Administration Staff
Webinar – Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles (Updated)
Artificial Intelligence and Machine Learning in Software as a Medical Device (Updated)
Guidances with Digital Health Content (Updated)
Medical Device Single Audit Program (MDSAP) (Updated)
Consumer Information: Lumicelli Direct Visualization System - P230014 (Lumicell, Inc.)
Medical Device Sterilization Town Hall: Sterilization Short Topics, Series Impact, Wrap Up, and Next Steps - December 4, 2024
- Printable Slides
Federal Register: Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

December 2, 2024

GUDID Data Trends (Updated)

CDRH Center for Device and Radiological Health Meetings and Conferences

03/25/2025	GMP QMS FREE 8-hour Training Hosted by The Auditing Group
02/19/2025	GMP QMS FREE 8-hour Training Hosted by The Auditing Group
01/14/2025	Webinar – Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
01/07/2025	GMP QMS FREE 8-hour Training Hosted by The Auditing Group

Whats New with CBER Center for Biologic Evaluation and Research

12/13/2024	November 20, 2024 Summary Basis for Regulatory Action - REGENECYTE
12/13/2024	CBER User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
12/12/2024	Accelerated Approval – Expedited Program for Serious Conditions; Draft Guidance for Industry
12/10/2024	Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma Webinar Date: February 19, 2025
12/10/2024	November 13, 2024 Summary Basis for Regulatory Action - KEBILIDI
12/9/2024	December 6, 2024 Approval Letter - VISTASEAL
12/9/2024	CBER Title 21 Vacancy Announcement, Information Technologist (Enterprise Architect), Series 2210, Band F, Center for Biologics Evaluation and Research (CBER), Office of Regulatory Operations (ORO), Immediate Office of the Director (IOD) Closes: December 20, 2024
12/9/2024	CBER Title 21 Vacancy Announcement, Consumer Safety Officer, Series 0696 Band B, Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ), Division of Inspections and Surveillance (DIS), Field Programs Branch (FPB) Closes: December 20, 2024

12/6/2024	Update to Important Information about Young Donor Plasma Infusions Offered for Profit
12/5/2024	Important Information for Blood Establishments Regarding Cybersecurity Resiliency
12/4/2024	Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff
12/4/2024	December 2, 2024 Approval Letter - JIVI
12/4/2024	CBER Title 21 Vacancy Announcement- Artificial Intelligence Specialist- AD-301-E- Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). Office of Regulatory Operations (ORO), Immediate Office of the Director (IOD) Closes: December 17, 2024
12/3/2024	Hurricane Helene: Baxter's manufacturing recovery in North Carolina
12/3/2024	PREHEVBRIO Voluntarily withdrawn from the market by the company.
11/27/2024	November 7, 2024 Summary Basis for Regulatory Action - AUCATZYL
11/27/2024	FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel)

CBER Meetings and Conferences

03/25/2025	GMP QMS FREE 8-hour Training Hosted by The Auditing Group
02/19/2025	GMP QMS FREE 8-hour Training Hosted by The Auditing Group
01/07/2025	GMP QMS FREE 8-hour Training Hosted by The Auditing Group

Guidance for Biologics

Weekly Rules Changes

Monday 2 December - 21 CFR Parts 510, 520, 522, 524, and 558
Tuesday 3 December - NONE
Wednesday 4 December - NONE
Thursday 5 December - NONE
Friday 6 December - NONE

Monday 9 December - NONE
Tuesday 10 December - NONE
Wednesday 11 December - NONE
Thursday 12 December - NONE
Friday 13 December - NONE

Monday 2 December 2024

Rules and Regulations - 21 CFR Parts 510, 520, 522, 524, and 558

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor

PDF Text

Notices

Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application 761393 for Condoliase Injection

PDF Text

Advancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities; Public Meeting; Request for Comments; Reopening of Public Comment Period

PDF Text

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KEBILIDI (eladocagene exuparvovec-tneq)

PDF Text

Tuesday 3 December 2024

Notices

Food and Drug Administration's Best Practices for Food and Drug Administration Communication With Interested Parties: Draft Report for Public Comment; Availability

PDF Text

Food and Drug Administration Report and Plan on Best Practices for Guidance; Availability

PDF Text

Wednesday 4 December 2024

Notices

Food Date Labeling

PDF Text

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability

PDF Text

Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

PDF Text

Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis; Draft Guidance for Industry; Availability

PDF Text

Thursday 5 December 2024

Notices

Determination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

PDF Text

Yong Sheng Jiao; Denial of Hearing; Final Debarment Order

PDF Text

Friday 6 December 2024

Notices

Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability

PDF Text

Monday 9 December 2024

Notices

Standardized Format for Electronic Submission of Marketing Application Content for the Planning of Bioresearch Monitoring Inspections for Center for Drug Evaluation and Research Submissions; Guidance for Industry; Availability

PDF Text

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement

PDF Text

Tuesday 10 December 2024

NONE

Wednesday 11 December 2024

NONE

Thursday 12 December 2024

Proposed Rules

Leprino Nutrition; Filing of Food Additive Petition

PDF Text

Notices

Advisory Committee; Science Board to the Food and Drug Administration; Renewal

PDF Text

Revocation of Authorization of Emergency Use of B. Braun Medical's Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES; Availability

PDF Text

Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability

PDF Text

Friday 13 December 2024

NONE

Drug Enforcement Administration (DEA)

Food and Drug Administration (FDA)

Tissue and Cell Key Resources

New and Handbooks
& Guidance

Standard Sterile Product
Manufacturing Handbook

Sterile Drug MFG Handbooks - SAVE 15%

- 21 CFR Part 11 with Scope and Application
- Part 210/211 GMPs
- ICH Q7 API GMPs
- EU GMPs Annex 1 Sterile Drug 2023

The International GMP
&
Master Medical Device

Get Both Books! $49.95
over 2000 pages!

GMP International Pharma. Master Reference Guide - 900+ pages of Guidance and Regulations

GMP Medical Device Master Reference Guide - Over 900 pages including EU Directive 2017/745

GMP Manufacturing Handbook - GMP Manufacturing Handbook - Drug, Biologics, Vaccines & APIs - Over 450 pages of Regulations and Guidance. Great for CMOs and GCP Industry

21 CFR 210/211 - Drug GMPs - Add Parts 11 Electronic Systems and 820 QSR for Device - Click to View

21 CFR 820 - Quality System Regulations - Include Audit Checklist with ISO 13485 References

21 CFR 112 Produce for Human Consumption also in a combination English / Spanish

21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook

21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination

In Vitro Diagnostics Master Handbook - Over 500 Pages including EU Directive 2017/746

21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook

21 CFR Part 117 - GMPs Hazard Analysis, and Risk-Based Preventive Controls for Food

Dietary Supplement Master Handbook - Includes Guides and Regulations for Supplements

21 CFR Part 117 - GMPs Hazard Analysis, and Risk-Based Preventive Controls for Food

Don't see what you are looking for? Contact John Cuspilich, QA/RA, at jcuspilich@fda.com

Drug Approvals:

December 13, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Crenessity NDA #218808	Crinecerfont	Capsule; Oral	Neurocrine
Crenessity NDA #218820	Crinecerfont	Solution; Oral	Neurocrine
Nemluvio BLA #761391	Nemolizumab-Ilto	Injectable; Injection	Galderma Labs Lp

December 12, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Bridion NDA #022225	Sugammadex Sodium	Solution; Intravenous	Msd Sub Merck
Terazosin Hydrochloride ANDA #074823	Terazosin Hydrochloride	Capsule; Oral	Apnar Pharma Lp
Terazosin Hydrochloride ANDA #074823	Terazosin Hydrochloride	Capsule; Oral	Apnar Pharma Lp
Nevirapine ANDA #077702	Nevirapine	Suspension; Oral	Aurobindo
Nevirapine ANDA #077702	Nevirapine	Suspension; Oral	Aurobindo
Opsumit NDA #204410	Macitentan	Tablet; Oral	Actelion
Glucagon ANDA #204468	Glucagon	Injectable; Injection	Mylan Labs Ltd
Acetazolamide ANDA #204691	Acetazolamide	Capsule, Extended Release; Oral	Nostrum Labs Inc
Acetazolamide ANDA #210423	Acetazolamide	Capsule, Extended Release; Oral	Alembic
Diazoxide ANDA #210799	Diazoxide	Suspension; Oral	Novitium Pharma
Macitentan ANDA #211107	Macitentan	Tablet; Oral	Torrent
Macitentan ANDA #211195	Macitentan	Tablet; Oral	Apotex
Macitentan ANDA #211198	Macitentan	Tablet; Oral	Aurobindo Pharma Ltd
Macitentan ANDA #211224	Macitentan	Tablet; Oral	Zydus Lifesciences
Nurtec Odt NDA #212728	Rimegepant Sulfate	Tablet, Orally Disintegrating; Oral	Pfizer
Vtama NDA #215272	Tapinarof	Cream; Topical	Dermavant Sci
Opsynvi NDA #218490	Macitentan; Tadalafil	Tablet; Oral	Actelion

December 11, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Allopurinol ANDA #070269	Allopurinol	Tablet; Oral	Sandoz
Cytarabine ANDA #076512	Cytarabine	Injectable; Injection	Fresenius Kabi Usa
Cytarabine ANDA #076512	Cytarabine	Injectable; Injection	Fresenius Kabi Usa
Cytarabine ANDA #076512	Cytarabine	Injectable; Injection	Fresenius Kabi Usa
Keytruda BLA #125514	Pembrolizumab	Solution; Intravenous	Merck Sharp Dohme
Cytarabine ANDA #201784	Cytarabine	Injectable; Injection	Rising
Cytarabine ANDA #201784	Cytarabine	Injectable; Injection	Rising
Cytarabine ANDA #201784	Cytarabine	Injectable; Injection	Rising
Aripiprazole ANDA #202683	Aripiprazole	Tablet; Oral	Orbion Pharms
Aripiprazole ANDA #202683	Aripiprazole	Tablet; Oral	Orbion Pharms
Aripiprazole ANDA #202683	Aripiprazole	Tablet; Oral	Orbion Pharms
Rexulti NDA #205422	Brexpiprazole	Tablet; Oral	Otsuka
Metformin Hydrochloride ANDA #211309	Metformin Hydrochloride	Solution; Oral	Saptalis Pharms
Metformin Hydrochloride ANDA #211309	Metformin Hydrochloride	Solution; Oral	Saptalis Pharms

December 10, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Heparin Sodium 10,000 Units In Sodium Chloride 0.45% NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Heparin Sodium 10,000 Units In Sodium Chloride 0.9% NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Heparin Sodium 12,500 Units In Sodium Chloride 0.9% NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Heparin Sodium 5,000 Units In Sodium Chloride 0.45% NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Heparin Sodium 5,000 Units In Sodium Chloride 0.9% NDA #018916	Heparin Sodium	Injectable; Injection	Hospira
Gabapentin ANDA #078428	Gabapentin	Capsule; Oral	Amneal Pharms Ny
Gabapentin ANDA #078428	Gabapentin	Capsule; Oral	Amneal Pharms Ny
Actemra BLA #125472	Tocilizumab	Injectable; Intravenous, Subcutaneous	Genentech
Actemra BLA #125472	Tocilizumab	Injectable; Intravenous, Subcutaneous	Genentech
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Esomeprazole Magnesium ANDA #208333	Esomeprazole Magnesium	Capsule, Delayed Rel Pellets; Oral	Alkem Labs Ltd
Bexarotene ANDA #210352	Bexarotene	Capsule; Oral	Cipla
Caspofungin Acetate ANDA #211263	Caspofungin Acetate	Powder; Intravenous	Areva Pharms
Caspofungin Acetate ANDA #211263	Caspofungin Acetate	Powder; Intravenous	Areva Pharms
Ezetimibe and Simvastatin ANDA #211663	Ezetimibe; Simvastatin	Tablet; Oral	Sciegen Pharms Inc
Eliglustat Tartrate ANDA #212369	Eliglustat Tartrate	Capsule; Oral	Cipla
Chlorpromazine Hydrochloride ANDA #216724	Chlorpromazine Hydrochloride	Injectable; Injection	Thinq Pharm-Cro Pvt
Phytonadione ANDA #217386	Phytonadione	Injectable; Injection	Gland Pharma Ltd

December 9, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Forane NDA #017624	Isoflurane	Liquid; Inhalation	Baxter Hlthcare
Fluconazole In Sodium Chloride 0.9% ANDA #076653	Fluconazole	Injectable; Injection	Dr Reddys
Fluconazole In Sodium Chloride 0.9% ANDA #076653	Fluconazole	Injectable; Injection	Dr Reddys
Fluconazole In Sodium Chloride 0.9% ANDA #076653	Fluconazole	Injectable; Injection	Dr Reddys
Fluconazole In Sodium Chloride 0.9% ANDA #076653	Fluconazole	Injectable; Injection	Dr Reddys
Fluoxetine Hydrochloride ANDA #076990	Fluoxetine Hydrochloride	Capsule; Oral	Sun Pharm Inds Ltd
Fluoxetine Hydrochloride ANDA #076990	Fluoxetine Hydrochloride	Capsule; Oral	Sun Pharm Inds Ltd
Fluoxetine Hydrochloride ANDA #076990	Fluoxetine Hydrochloride	Capsule; Oral	Sun Pharm Inds Ltd
Fluoxetine Hydrochloride ANDA #076990	Fluoxetine Hydrochloride	Capsule; Oral	Sun Pharm Inds Ltd
Levonorgestrel and Ethinyl Estradiol ANDA #203871	Ethinyl Estradiol; Levonorgestrel	Tablet; Oral	Amneal Pharms
Levonorgestrel and Ethinyl Estradiol ANDA #203871	Ethinyl Estradiol; Levonorgestrel	Tablet; Oral	Amneal Pharms
Imatinib Mesylate ANDA #204644	Imatinib Mesylate	Tablet; Oral	Mylan
Dihydroergotamine Mesylate ANDA #207264	Dihydroergotamine Mesylate	Injectable; Injection	Sagent Pharms Inc
Rosuvastatin Calcium ANDA #208898	Rosuvastatin Calcium	Tablet; Oral	Msn
Rosuvastatin Calcium ANDA #208898	Rosuvastatin Calcium	Tablet; Oral	Msn
Rosuvastatin Calcium ANDA #208898	Rosuvastatin Calcium	Tablet; Oral	Msn
Rosuvastatin Calcium ANDA #208898	Rosuvastatin Calcium	Tablet; Oral	Msn
Tromethamine ANDA #211558	Tromethamine	Solution; Injection	B Braun Medical Inc
Rybelsus NDA #213051	Semaglutide	Tablet; Oral	Novo
Rybelsus NDA #213051	Semaglutide	Tablet; Oral	Novo
Iobenguane I-123 ANDA #213637	Iobenguane Sulfate I-123	Solution; Intravenous	Bwxt Medcl
Varenicline Tartrate ANDA #215048	Varenicline Tartrate	Tablet; Oral	Macleods Pharms Ltd
Triamcinolone Acetonide ANDA #215254	Triamcinolone Acetonide	Injectable; Injection	Hikma
Pregabalin ANDA #215755	Pregabalin	Capsule; Oral	Strides Pharma
Pregabalin ANDA #215755	Pregabalin	Capsule; Oral	Strides Pharma
Ertugliflozin ANDA #216947	Ertugliflozin	Tablet; Oral	Aurobindo Pharma Ltd
Ertugliflozin ANDA #216947	Ertugliflozin	Tablet; Oral	Aurobindo Pharma Ltd
Tryvio NDA #217686	Aprocitentan	Tablet; Oral	Idorsia

December 6, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Isovue-128 NDA #018735	Iopamidol	Injectable; Injection	Bracco
Isovue-200 NDA #018735	Iopamidol	Injectable; Injection	Bracco
Isovue-250 NDA #018735	Iopamidol	Injectable; Injection	Bracco
Isovue-300 NDA #018735	Iopamidol	Injectable; Injection	Bracco
Isovue-370 NDA #018735	Iopamidol	Injectable; Injection	Bracco
Isovue-M 200 NDA #018735	Iopamidol	Injectable; Injection	Bracco
Isovue-M 300 NDA #018735	Iopamidol	Injectable; Injection	Bracco
Zolpidem Tartrate ANDA #202657	Zolpidem Tartrate	Tablet; Sublingual	Norvium Bioscience
Zolpidem Tartrate ANDA #202657	Zolpidem Tartrate	Tablet; Sublingual	Norvium Bioscience
Estradiol ANDA #206685	Estradiol	Film, Extended Release; Transdermal	Mylan Technologies
Estradiol ANDA #206685	Estradiol	Film, Extended Release; Transdermal	Mylan Technologies
Estradiol ANDA #206685	Estradiol	Film, Extended Release; Transdermal	Mylan Technologies
Estradiol ANDA #206685	Estradiol	Film, Extended Release; Transdermal	Mylan Technologies
Rivaroxaban ANDA #208549	Rivaroxaban	Tablet; Oral	Prinston Inc
Lurasidone Hydrochloride ANDA #210388	Lurasidone Hydrochloride	Tablet; Oral	Jubilant Generics
Baclofen ANDA #214445	Baclofen	Solution; Oral	Rubicon
Onyda Xr NDA #217645	Clonidine Hydrochloride	Suspension, Extended Release; Oral	Tris Pharma Inc

December 5, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Ic-Green NDA #011525	Indocyanine Green	Injectable; Injection	Renew Pharms
Reyataz NDA #021567	Atazanavir Sulfate	Capsule; Oral	Bristol Myers Squibb
Divalproex Sodium ANDA #079163	Divalproex Sodium	Tablet, Delayed Release; Oral	Unichem Labs Ltd
Divalproex Sodium ANDA #079163	Divalproex Sodium	Tablet, Delayed Release; Oral	Unichem Labs Ltd
Divalproex Sodium ANDA #079163	Divalproex Sodium	Tablet, Delayed Release; Oral	Unichem Labs Ltd
Divalproex Sodium ANDA #079163	Divalproex Sodium	Tablet, Delayed Release; Oral	Unichem Labs Ltd
Atorvastatin Calcium ANDA #091226	Atorvastatin Calcium	Tablet; Oral	Mylan Pharms Inc
Atorvastatin Calcium ANDA #091226	Atorvastatin Calcium	Tablet; Oral	Mylan Pharms Inc
Reyataz NDA #206352	Atazanavir Sulfate	Powder; Oral	Bristol Myers Squibb
Atorvastatin Calcium ANDA #207687	Atorvastatin Calcium	Tablet; Oral	Accord Hlthcare
Atorvastatin Calcium ANDA #207687	Atorvastatin Calcium	Tablet; Oral	Accord Hlthcare
Abacavir \|\| Dolutegravir \|\| Lamivudine ANDA #212181	Abacavir \|\| Dolutegravir \|\| Lamivudine	Tablet	Emcure Pharms Ltd
Calcitonin-Salmon ANDA #212675	Calcitonin Salmon	Injectable; Injection	Fresenius Kabi Usa

December 4, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Atorvastatin Calcium ANDA #076477	Atorvastatin Calcium	Tablet; Oral	Sun Pharm Inds Ltd
Atorvastatin Calcium ANDA #076477	Atorvastatin Calcium	Tablet; Oral	Sun Pharm Inds Ltd
Atorvastatin Calcium ANDA #076477	Atorvastatin Calcium	Tablet; Oral	Sun Pharm Inds Ltd
Atorvastatin Calcium ANDA #090548	Atorvastatin Calcium	Tablet; Oral	Apotex Inc
Atorvastatin Calcium ANDA #090548	Atorvastatin Calcium	Tablet; Oral	Apotex Inc
Fulvestrant ANDA #208811	Fulvestrant	Solution; Intramuscular	Eugia Pharma
Fulvestrant ANDA #208811	Fulvestrant	Solution; Intramuscular	Eugia Pharma
Fulvestrant ANDA #208811	Fulvestrant	Solution; Intramuscular	Eugia Pharma
Fulvestrant ANDA #208811	Fulvestrant	Solution; Intramuscular	Eugia Pharma
Fulvestrant ANDA #208811	Fulvestrant	Solution; Intramuscular	Eugia Pharma
Fulvestrant ANDA #208811	Fulvestrant	Solution; Intramuscular	Eugia Pharma
Fulvestrant ANDA #208811	Fulvestrant	Solution; Intramuscular	Eugia Pharma
Emtricitabine and Tenofovir Disoproxil Fumarate ANDA #212689	Emtricitabine; Tenofovir Disoproxil Fumarate	Tablet; Oral	Zydus Pharms
Emtricitabine and Tenofovir Disoproxil Fumarate ANDA #212689	Emtricitabine; Tenofovir Disoproxil Fumarate	Tablet; Oral	Zydus Pharms
Emtricitabine and Tenofovir Disoproxil Fumarate ANDA #212689	Emtricitabine; Tenofovir Disoproxil Fumarate	Tablet; Oral	Zydus Pharms
Emtricitabine and Tenofovir Disoproxil Fumarate ANDA #212689	Emtricitabine; Tenofovir Disoproxil Fumarate	Tablet; Oral	Zydus Pharms
Tadalafil ANDA #216279	Tadalafil	Tablet; Oral	Shandong
Tadalafil ANDA #216279	Tadalafil	Tablet; Oral	Shandong
Doxycycline Hyclate ANDA #217487	Doxycycline Hyclate	Injectable; Injection	Amneal
Pazopanib Hydrochloride ANDA #219034	Pazopanib Hydrochloride	Tablet; Oral	Eugia Pharma
Imfinzi BLA #761069	Durvalumab	Injectable; Injection	Astrazeneca Uk Ltd
Bizengri BLA #761352	Zenocutuzumab-Zbco	Injection; Solution	Merus N.V.

December 3, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Vosol Hc NDA #012770	Acetic Acid, Glacial; Hydrocortisone	Solution/Drops; Otic	Saptalis Pharms
Vosol Hc NDA #012770	Acetic Acid, Glacial; Hydrocortisone	Solution/Drops; Otic	Saptalis Pharms
Zosyn NDA #050684	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Wyeth Pharms
Merrem NDA #050706	Meropenem	Injectable; Injection	Pfizer
Zosyn In Plastic Container NDA #050750	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Baxter Hlthcare Corp
Piperacillin and Tazobactam ANDA #065362	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Sandoz
Piperacillin and Tazobactam ANDA #065363	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Sandoz
Piperacillin and Tazobactam ANDA #065458	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Steriscience Speclts
Piperacillin and Tazobactam ANDA #065498	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Eugia Pharma Speclts
Meropenem and Sodium Chloride In Duplex Container NDA #202106	Meropenem	Powder; Intravenous	B Braun Medical Inc
Bosulif NDA #203341	Bosutinib Monohydrate	Tablet; Oral	Pf Prism Cv
Piperacillin and Tazobactam ANDA #203557	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Sandoz
Piperacillin and Tazobactam ANDA #203719	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Fresenius Kabi
Piperacillin and Tazobactam ANDA #203720	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Fresenius Kabi
Piperacillin and Tazobactam ANDA #204959	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Shandong
Metronidazole In Plastic Container ANDA #206191	Metronidazole	Injectable; Injection	Inforlife
Piperacillin and Tazobactam ANDA #206996	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Wockhardt Bio Ag
Piperacillin and Tazobactam ANDA #207146	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Wockhardt Bio Ag
Lurasidone Hydrochloride ANDA #208002	Lurasidone Hydrochloride	Tablet; Oral	Amneal Pharms Co
Lurasidone Hydrochloride ANDA #208002	Lurasidone Hydrochloride	Tablet; Oral	Amneal Pharms Co
Lurasidone Hydrochloride ANDA #208002	Lurasidone Hydrochloride	Tablet; Oral	Amneal Pharms Co
Lurasidone Hydrochloride ANDA #208002	Lurasidone Hydrochloride	Tablet; Oral	Amneal Pharms Co
Lurasidone Hydrochloride ANDA #208002	Lurasidone Hydrochloride	Tablet; Oral	Amneal Pharms Co
Piperacillin and Tazobactam ANDA #208674	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Sagent Pharms Inc
Piperacillin and Tazobactam ANDA #208675	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Sagent Pharms Inc
Zilretta NDA #208845	Triamcinolone Acetonide	For Suspension, Extended Release; Intra-Articular	Pacira Pharms Inc
Zilretta NDA #208845	Triamcinolone Acetonide	For Suspension, Extended Release; Intra-Articular	Pacira Pharms Inc
Vabomere NDA #209776	Meropenem; Vaborbactam	Powder; Intravenous	Rempex
Norepinephrine Bitartrate In 0.9% Sodium Chloride NDA #214628	Norepinephrine Bitartrate	Solution; Intravenous	Long Grove Pharms
Meropenem NDA #215212	Meropenem	Powder; Intravenous	Hq Spclt Pharma
Paliperidone Palmitate ANDA #215682	Paliperidone Palmitate	Injection; Suspension	Mylan Pharmaceuticals Inc A Viatris Co
Phyrago NDA #216099	Dasatinib	Tablet; Oral	Nanocopoeia
Aripiprazole ANDA #216608	Aripiprazole	For Suspension, Extended Release; Intramuscular	Mylan
Piperacillin and Tazobactam ANDA #217243	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Shandong
Piperacillin and Tazobactam ANDA #217409	Piperacillin Sodium; Tazobactam Sodium	Injectable; Injection	Eugia Pharma
Piperacillin and Tazobactam ANDA #217409	Piperacillin,Tazobactam	Injection; Powder,For Solution	Eugia Pharma
Oseltamivir Phosphate ANDA #217451	Oseltamivir Phosphate	Capsule; Oral	Cediprof Inc
Colestipol Hydrochloride ANDA #217462	Colestipol Hydrochloride	Tablet; Oral	Riconpharma Llc
Bosulif NDA #217729	Bosutinib Monohydrate	Capsule; Oral	Pf Prism Cv
Olopatadine Hydrochloride ANDA #217856	Olopatadine Hydrochloride	Solution; Ophthalmic	Alembic Pharms Ltd
Cyclophosphamide ANDA #218282	Cyclophosphamide	Capsule; Oral	Nextsource
Abacavir; Dolutegravir; Lamivudine ANDA #218383	Abacavir;Dolutegravir;Lamivudine	Tablet; Oral	Lupin Ltd
Topiramate ANDA #218695	Topiramate	Capsule, Extended Release; Oral	Amta
Tyenne BLA #761275	Tocilizumab-Aazg	Injectable; Intravenous	Fresenius Kabi Usa
Tyenne BLA #761275	Tocilizumab-Aazg	Injectable; Intravenous	Fresenius Kabi Usa
Tyenne BLA #761275	Tocilizumab-Aazg	Injectable; Subcutaneous	Fresenius Kabi Usa
Tyenne BLA #761275	Tocilizumab-Aazg	Injectable; Subcutaneous	Fresenius Kabi Usa
Tofidence BLA #761354	Tocilizumab-Bavi	Injectable; Injection	Biogen Ma
Tofidence BLA #761354	Tocilizumab-Bavi	Injectable; Injection	Biogen Ma

December 2, 2024

Drug Name and Application Number	Active Ingredient	Dosage Form/ Route	Company
Ifex NDA #019763	Ifosfamide	Injectable; Injection	Baxter Hlthcare
Ifex/Mesnex Kit NDA #019763	Ifosfamide; Mesna	Injectable; Injection	Baxter Hlthcare
Gabapentin ANDA #077242	Gabapentin	Capsule; Oral	Sun Pharm Inds Ltd
Gabapentin ANDA #077242	Gabapentin	Capsule; Oral	Sun Pharm Inds Ltd
Gabapentin ANDA #077242	Gabapentin	Capsule; Oral	Sun Pharm Inds Ltd
Gabapentin ANDA #077242	Gabapentin	Capsule; Oral	Sun Pharm Inds Ltd
Gabapentin ANDA #077242	Gabapentin	Capsule; Oral	Sun Pharm Inds Ltd
Gabapentin ANDA #077242	Gabapentin	Capsule; Oral	Sun Pharm Inds Ltd
Gabapentin ANDA #077525	Gabapentin	Tablet; Oral	Sun Pharm Inds Ltd
Gabapentin ANDA #077525	Gabapentin	Tablet; Oral	Sun Pharm Inds Ltd
Gabapentin ANDA #077525	Gabapentin	Tablet; Oral	Sun Pharm Inds Ltd
Gabapentin ANDA #077525	Gabapentin	Tablet; Oral	Sun Pharm Inds Ltd
Efavirenz ANDA #078509	Efavirenz	Tablet; Oral	Strides Pharma
Provayblue NDA #204630	Methylene Blue	Solution; Intravenous	Provepharm Sas
Pemetrexed NDA #210661	Pemetrexed Dipotassium	Powder; Intravenous	Avyxa Holdings
Clobetasol Propionate ANDA #214345	Clobetasol Propionate	Spray; Topical	Macleods Pharms Ltd
Tecvayli BLA #761291	Teclistamab-Cqyv	Injectable; Injection	Janssen Biotech
Talvey BLA #761342	Talquetamab-Tgvs	Injectable; Injection	Janssen Biotech

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