GXPNews - FDA News & Announcements September 30 - October 4, 2024
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Whats New with CDER
Drug News and Events

October 4, 2024

October 3, 2024

October 2, 2024

October 1, 2024

September 27, 2024
CDER Meetings and Conferences
01/07/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
12/04/2024 December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee
11/21/2024 M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance
11/19/2024 November 19, 2024: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Psychopharmacologic Drugs Advisory Committee Meeting Announcement
11/15/2024 Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age
11/13/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
11/12/2024 Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies
11/07/2024 Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age
11/07/2024 16th Annual Sentinel Initiative Public Workshop
11/06/2024 Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products
11/04/2024 2024 Scientific Computing and Digital Transformation Symposium
10/31/2024 UPDATED PUBLIC PARTICIPATION INFORMATION: October 31, 2024: Meeting of Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
10/29/2024 October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee
10/28/2024 2024 DIA/FDA Oligonucleotide-Based Therapeutics Conference
10/16/2024 Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub
10/16/2024 Global IDMP Implementation - Getting Closer to the Goal
10/15/2024 FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop
10/10/2024 October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee
10/09/2024 ICH M12 Drug-Drug Interaction Studies Final Guidance
10/07/2024 Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products - Workshop
10/07/2024 Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis: A Scientific Workshop
10/07/2024 Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products - Public
 
Dietary Supplements

Dietary Supplements

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Applications & Submissions

Related Resources
 
Whats New with CDRH
Medical Device News and Events

October 4, 2024

October 3, 2024

October 2, 2024

October 1, 2024

September 30, 2024
CDRH Center for Device and Radiological Health Meetings and Conferences
01/07/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
12/03/2024 Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs)
11/13/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
11/06/2024 FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference
11/06/2024 Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices
10/24/2024 FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic Products (IVDs)
10/15/2024 Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle
10/09/2024 Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
10/08/2024 Webinar - The Voluntary Improvement Program: How to Enroll, Opportunities, and Best Practices
09/24/2024 Webinar - Labeling Requirements for In Vitro Diagnostic Products (IVD), Including LDTs, Under 21 CFR 809.10(b)
09/19/2024 Public Workshop - Food and Drug Administration/National Institutes of Health Joint Workshop: Developing Implanted Brain-Computer Interface Clinical Outcome Assessments to Demonstrate Benefit
09/11/2024 Medical Device Sterilization Town Hall: Sterility Master Files and Effective Use in Premarket Submissions
09/10/2024 Webinar - Final Guidance: Remanufacturing of Medical Devices
 
Whats New with CBER Center for Biologic Evaluation and Research
10/4/2024 October 3, 2024 Approval Letter - MRESVIA
10/3/2024 CBER Cures Vacancy Announcement - Lead Management Analyst (Data and UFA Tracking Lead), Band C, Office of Management (OM), Division of Human Capital (DHC), Workforce Management Branch (WMB)
Closes: October 17, 2024
10/2/2024 October 1, 2024 Approval Letter - Octaplas
10/2/2024 Complete List of Licensed Products and Establishments
Update
10/2/2024 Complete List of Substantially Equivalent 510(k) Device Applications
Update
10/2/2024 Complete List of Currently Approved Premarket Approvals (PMAs)
Update
10/2/2024 Complete List of Currently Approved NDA and ANDA Application Submissions
Update
10/2/2024 Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry
10/2/2024 Cellular, Tissue, and Gene Therapies Advisory Committee Meeting Announcement
November 21, 2024
10/1/2024 September 27, 2024 Approval Letter - VISTASEAL
10/1/2024 Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Deviation Codes
10/1/2024 Biological Product Deviation Reporting - Blood Product Codes
10/1/2024 Biological Product Deviation Reporting and HCT/P Deviation Reporting -- Non-Blood Product Codes
9/30/2024 CBER Title 21 Vacancy Announcement - Division Director, AD-0343-Band F, Division of Acquisition and Budget Resources (DABR), Office of Management (OM)
Closes: October 4, 2024
CBER Meetings and Conferences
01/07/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
11/13/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
10/25/2024 Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants
Guidance for Biologics
 
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Weekly Rules Changes
  • Monday 30 October - NONE
  • Tueday 1 October - NONE
  • Wednesday 2 October - NONE
  • Thursday 3 October - NONE
  • Friday 4 October - NONE
Monday 30 September 2024

Notices

Statement of Organization, Functions, and Delegations of Authority

Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Availability

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Draft Guidance for Industry; Availability

Safety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and Food and Drug Administration Staff; Availability

Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Guidance for Industry and Food and Drug Administration Staff; Availability

Request for Nominations for Individuals and Consumer Organizations for Advisory Committees

Tuesday 1 October 2024

Notices

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms

Wednesday 2 October 2024

Notices

Agency Information Collection Activities; Proposed Collection; Comment Request; Promotion of Prescription Drugs Within a Talk Show Format

Determination That AUGMENTIN XR (Amoxicillin; Clavulanate Potassium) Extended-Release Tablets, 1 Gram; Equivalent to 62.5 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry; Availability

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 125586/546 From AstraZeneca AB for Andexxa (Coagulation Factor Xa (Recombinant), Inactivated -zhzo); November 21, 2024

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 210934 for Sotagliflozin Oral Tablet

Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence; Program Announcement

Thursday 3 October 2024

NONE

 
Friday 4 October 2024

NONE

 

 
 
 
 
 
 
 
 
 
 
 

Drug Enforcement Administration (DEA)

Food and Drug Administration (FDA)

Tissue and Cell Key Resources
 

New and Handbooks
& Guidance

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Standard Sterile Product
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Sterile Drug MFG Handbooks - SAVE 15%

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

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

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

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

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

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

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

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

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 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

 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:

October 3, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Locoid Lipocream
NDA #020769		 Hydrocortisone Butyrate Cream; Topical Precision Dermat
Butorphanol Tartrate
ANDA #075759		 Butorphanol Tartrate Spray, Metered; Nasal Rising
Hydrocodone Bitartrate and Ibuprofen
ANDA #076642		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Amneal Pharms Ny
Hydrocodone Bitartrate and Ibuprofen
ANDA #076642		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Amneal Pharms Ny
Reprexain
ANDA #076642		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Amneal Pharms Ny
Reprexain
ANDA #076642		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Amneal Pharms Ny
Gabapentin
ANDA #078926		 Gabapentin Tablet; Oral Zydus Pharms Usa Inc
Gabapentin
ANDA #078926		 Gabapentin Tablet; Oral Zydus Pharms Usa Inc
Opdivo
BLA #125554		 Nivolumab Injectable; Injection Bristol Myers Squibb

October 2, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Phenytoin Sodium
ANDA #040573		 Phenytoin Sodium Injectable; Injection Acella
Phenytoin Sodium
ANDA #040573		 Phenytoin Sodium Injectable; Injection Acella
Nitrofurantoin
ANDA #077025		 Nitrofurantoin, Macrocrystalline Capsule; Oral Aurobindo Pharma Usa
Nitrofurantoin
ANDA #077025		 Nitrofurantoin, Macrocrystalline Capsule; Oral Aurobindo Pharma Usa
Hydrocodone Bitartrate and Ibuprofen
ANDA #077454		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Ani Pharms
Hydrocodone Bitartrate and Ibuprofen
ANDA #077454		 Hydrocodone Bitartrate; Ibuprofen Tablet; Oral Ani Pharms
Gabapentin
ANDA #077662		 Gabapentin Tablet; Oral Glenmark Pharms Ltd
Solifenacin Succinate
ANDA #205484		 Solifenacin Succinate Tablet; Oral Jubilant Generics
Alcaftadine
ANDA #209290		 Alcaftadine Solution/Drops; Ophthalmic Alembic
Nilotinib
ANDA #218544		 Nilotinib Capsule; Oral Msn Laboratories Private Ltd

October 1, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Furosemide
NDA #018267		 Furosemide Injectable; Injection Hikma
Furosemide
NDA #018579		 Furosemide Injectable; Injection Am Regent
Furosemide
NDA #018667		 Furosemide Injectable; Injection Hospira
Furosemide
NDA #018902		 Furosemide Injectable; Injection Fresenius Kabi Usa
Methylphenidate Hydrochloride
ANDA #079031		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Barr Labs Inc
Methylphenidate Hydrochloride
ANDA #079031		 Methylphenidate Hydrochloride Capsule, Extended Release; Oral Barr Labs Inc
Hepzato
NDA #201848		 Melphalan Hydrochloride Powder; Intra-Arterial Delcath Systems Inc
Mekinist
NDA #204114		 Trametinib Dimethyl Sulfoxide Tablet; Oral Novartis
Fingolimod Hydrochloride
ANDA #207933		 Fingolimod Hydrochloride Capsule; Oral Hetero Labs Ltd V
Fingolimod Hydrochloride
ANDA #207933		 Fingolimod Hydrochloride Capsule; Oral Hetero Labs Ltd V
Bupropion Hydrochloride
ANDA #211200		 Bupropion Hydrochloride Tablet, Extended Release; Oral Zhejiang Jutai Pharm
Bupropion Hydrochloride
ANDA #211200		 Bupropion Hydrochloride Tablet, Extended Release; Oral Zhejiang Jutai Pharm
Bupropion Hydrochloride
ANDA #211200		 Bupropion Hydrochloride Tablet, Extended Release; Oral Zhejiang Jutai Pharm
Bupropion Hydrochloride
ANDA #211200		 Bupropion Hydrochloride Tablet, Extended Release; Oral Zhejiang Jutai Pharm
Bupropion Hydrochloride
ANDA #211200		 Bupropion Hydrochloride Tablet, Extended Release; Oral Zhejiang Jutai Pharm
Lamotrigine
ANDA #211821		 Lamotrigine Tablet, Extended Release; Oral Alembic
Dabigatran Etexilate Mesylate
ANDA #213879		 Dabigatran Etexilate Mesylate Capsule; Oral Msn
Dabigatran Etexilate Mesylate
ANDA #213879		 Dabigatran Etexilate Mesylate Capsule; Oral Msn
Varenicline Tartrate
ANDA #215931		 Varenicline Tartrate Tablet; Oral Dr Reddys
Eribulin Mesylate
ANDA #217250		 Eribulin Mesylate Solution; Intravenous Baxter Hlthcare Corp
Nebivolol Hydrochloride
ANDA #217397		 Nebivolol Hydrochloride Tablet; Oral Msn
Mekinist
NDA #217513		 Trametinib Solution; Oral Novartis
Mekinist
NDA #217513		 Trametinib Tablet; Oral Novartis
Mekinist
NDA #217513		 Trametinib Dimethyl Sulfoxide Solution; Oral Novartis

September 30, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Orphenadrine Citrate, Aspirin, and Caffeine
ANDA #074654		 Aspirin; Caffeine; Orphenadrine Citrate Tablet; Oral Sandoz
Dapsone
ANDA #213847		 Dapsone Gel; Topical Mylan
Dapsone
ANDA #213847		 Dapsone Gel; Topical Mylan
Docetaxel
ANDA #214575		 Docetaxel Injectable; Injection Eugia Pharma
Lumakras
NDA #214665		 Sotorasib Tablet; Oral Amgen Inc
Quviviq
NDA #214985		 Daridorexant Hydrochloride Tablet; Oral Idorsia
Quviviq
NDA #214985		 Daridorexant Hydrochloride Tablet; Oral Idorsia
Quviviq
NDA #214985		 Daridorexant Hydrochloride Tablet; Oral Idorsia
Octreotide Acetate
ANDA #216807		 Octreotide Acetate Injectable; Injection Gland Pharma Ltd
Drospirenone
ANDA #216936		 Drospirenone Tablet; Oral Lupin Ltd
Daybue
NDA #217026		 Trofinetide Solution; Oral Acadia Pharms Inc
Daybue
NDA #217026		 Trofinetide Solution; Oral Acadia Pharms Inc
Daybue
NDA #217026		 Trofinetide Solution; Oral Acadia Pharms Inc
Enzalutamide
ANDA #217322		 Enzalutamide Tablet; Oral Zydus Pharms Usa Inc
Atorvastatin Calcium
ANDA #217634		 Atorvastatin Calcium Tablet; Oral Strides Pharma
Atorvastatin Calcium
ANDA #217634		 Atorvastatin Calcium Tablet; Oral Strides Pharma
Prochlorperazine Maleate
ANDA #218912		 Prochlorperazine Maleate Tablet; Oral Leading

September 27, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Diphenoxylate Hydrochloride and Atropine Sulfate
ANDA #040357		 Atropine Sulfate; Diphenoxylate Hydrochloride Tablet; Oral Strides Pharma
Ampicillin and Sulbactam
ANDA #065240		 Ampicillin Sodium; Sulbactam Sodium Injectable; Injection Sandoz
Ampicillin and Sulbactam
ANDA #065241		 Ampicillin Sodium; Sulbactam Sodium Injectable; Injection Sandoz
Ampicillin and Sulbactam
ANDA #065403		 Ampicillin Sodium; Sulbactam Sodium Injectable; Injection Acs Dobfar
Ampicillin and Sulbactam
ANDA #065403		 Ampicillin Sodium; Sulbactam Sodium Injectable; Injection Acs Dobfar
Ampicillin and Sulbactam
ANDA #065403		 Ampicillin Sodium; Sulbactam Sodium Injectable; Injection Acs Dobfar
Ampicillin and Sulbactam
ANDA #065403		 Ampicillin Sodium; Sulbactam Sodium Injectable; Injection Acs Dobfar
Doxazosin Mesylate
ANDA #075580		 Doxazosin Mesylate Tablet; Oral Apotex
Doxazosin Mesylate
ANDA #075580		 Doxazosin Mesylate Tablet; Oral Apotex
Doxazosin Mesylate
ANDA #075580		 Doxazosin Mesylate Tablet; Oral Apotex
Doxazosin Mesylate
ANDA #075580		 Doxazosin Mesylate Tablet; Oral Apotex
Riluzole
ANDA #076173		 Riluzole Tablet; Oral Impax Labs
Riluzole
ANDA #076173		 Riluzole Tablet; Oral Impax Labs
Nateglinide
ANDA #077462		 Nateglinide Tablet; Oral Watson Labs
Nateglinide
ANDA #077462		 Nateglinide Tablet; Oral Watson Labs
Alendronate Sodium
ANDA #090124		 Alendronate Sodium Tablet; Oral Aurobindo Pharma
Alendronate Sodium
ANDA #090124		 Alendronate Sodium Tablet; Oral Aurobindo Pharma
Alendronate Sodium
ANDA #090124		 Alendronate Sodium Tablet; Oral Aurobindo Pharma
Celecoxib
ANDA #200562		 Celecoxib Capsule; Oral Watson Labs Inc
Celecoxib
ANDA #200562		 Celecoxib Capsule; Oral Watson Labs Inc
Celecoxib
ANDA #200562		 Celecoxib Capsule; Oral Watson Labs Inc
Phenytoin
ANDA #200691		 Phenytoin Tablet, Chewable; Oral Rising
Phenytoin
ANDA #200691		 Phenytoin Tablet, Chewable; Oral Rising
Phenytoin
ANDA #200691		 Phenytoin Tablet, Chewable; Oral Rising
Phenytoin
ANDA #200691		 Phenytoin Tablet, Chewable; Oral Rising
Phenytoin
ANDA #200691		 Phenytoin Tablet, Chewable; Oral Rising
Phenytoin
ANDA #200691		 Phenytoin Tablet, Chewable; Oral Rising
Ampicillin and Sulbactam
ANDA #201406		 Ampicillin Sodium; Sulbactam Sodium Injectable; Injection Antibiotice
Ampicillin and Sulbactam
ANDA #201406		 Ampicillin Sodium; Sulbactam Sodium Injectable; Injection Antibiotice
Ampicillin and Sulbactam
ANDA #201406		 Ampicillin Sodium; Sulbactam Sodium Injectable; Injection Antibiotice
Metformin Hydrochloride
ANDA #202917		 Metformin Hydrochloride Tablet, Extended Release; Oral Sun Pharm
Metformin Hydrochloride
ANDA #202917		 Metformin Hydrochloride Tablet, Extended Release; Oral Sun Pharm
Xeljanz
NDA #203214		 Tofacitinib Citrate Tablet; Oral Pf Prism Cv
Montelukast Sodium
ANDA #203366		 Montelukast Sodium Tablet; Oral Macleods Pharms Ltd
Montelukast Sodium
ANDA #203366		 Montelukast Sodium Tablet; Oral Macleods Pharms Ltd
Montelukast Sodium
ANDA #203366		 Montelukast Sodium Tablet; Oral Macleods Pharms Ltd
Montelukast Sodium
ANDA #203366		 Montelukast Sodium Tablet; Oral Macleods Pharms Ltd
Montelukast Sodium
ANDA #203366		 Montelukast Sodium Tablet; Oral Macleods Pharms Ltd
Pitavastatin Calcium
ANDA #206070		 Pitavastatin Calcium Tablet; Oral Mylan
Rosuvastatin Calcium
ANDA #207453		 Rosuvastatin Calcium Tablet; Oral Cadila Pharms Ltd
Rosuvastatin Calcium
ANDA #207453		 Rosuvastatin Calcium Tablet; Oral Cadila Pharms Ltd
Xeljanz Xr
NDA #208246		 Tofacitinib Citrate Tablet, Extended Release; Oral Pfizer
Penciclovir
ANDA #212368		 Penciclovir Cream; Topical Padagis Israel
Xeljanz
NDA #213082		 Tofacitinib Citrate Solution; Oral Pfizer
Bynfezia
NDA #213224		 Octreotide Acetate Injectable; Injection Sun Pharm Inds Inc
Retevmo
NDA #213246		 Selpercatinib Capsule; Oral Loxo Oncol Eli Lilly
Retevmo
NDA #213246		 Selpercatinib Capsule; Oral Loxo Oncol Eli Lilly
Flyrcado
NDA #215168		 Flurpiridaz F 18 Injectable; Injection Ge Healthcare
Retevmo
NDA #218160		 Selpercatinib Capsule; Oral Loxo Oncol Eli Lilly
Retevmo
NDA #218160		 Selpercatinib Capsule; Oral Loxo Oncol Eli Lilly
Retevmo
NDA #218160		 Selpercatinib Tablet; Oral Loxo Oncol Eli Lilly
Retevmo
NDA #218160		 Selpercatinib Tablet; Oral Loxo Oncol Eli Lilly
Cephalexin
ANDA #218817		 Cephalexin Tablet; Oral Aurobindo Pharma Ltd
Cephalexin
ANDA #218947		 Cephalexin Tablet; Oral Alkem Labs Ltd
Dupixent
BLA #761055		 Dupilumab Injectable; Injection Regeneron Pharmaceuticals
Otulfi
BLA #761379		 Ustekinumab-Aauz Injectable; Injection Fresenius Kabi Usa

September 26, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Hydroxyzine Hydrochloride
ANDA #040391		 Hydroxyzine Hydrochloride Syrup; Oral Pai Holdings Pharm
Hydroxyzine Hydrochloride
ANDA #040391		 Hydroxyzine Hydrochloride Syrup; Oral Pai Holdings Pharm
Nalbuphine Hydrochloride
ANDA #074471		 Nalbuphine Hydrochloride Injectable; Injection Dr Reddys
Diclofenac Potassium
ANDA #075219		 Diclofenac Potassium Tablet; Oral Teva
Diclofenac Potassium
ANDA #075219		 Diclofenac Potassium Tablet; Oral Teva
Leflunomide
ANDA #077090		 Leflunomide Tablet; Oral Apotex Inc
Leflunomide
ANDA #077090		 Leflunomide Tablet; Oral Apotex Inc
Diclofenac Sodium
ANDA #077863		 Diclofenac Sodium Tablet, Delayed Release; Oral Unique
Diclofenac Sodium
ANDA #077863		 Diclofenac Sodium Tablet, Delayed Release; Oral Unique
Diclofenac Sodium
ANDA #077863		 Diclofenac Sodium Tablet, Delayed Release; Oral Unique
Ciprofloxacin In Dextrose 5% In Plastic Container
ANDA #078252		 Ciprofloxacin Injectable; Injection Inforlife
Diclofenac Sodium
ANDA #090066		 Diclofenac Sodium Tablet, Delayed Release; Oral Unique
Diclofenac Sodium
ANDA #090066		 Diclofenac Sodium Tablet, Delayed Release; Oral Unique
Diclofenac Sodium
ANDA #090066		 Diclofenac Sodium Tablet, Delayed Release; Oral Unique
Levofloxacin In Dextrose 5% In Plastic Container
ANDA #090343		 Levofloxacin Injectable; Injection Inforlife
Levofloxacin In Dextrose 5% In Plastic Container
ANDA #090343		 Levofloxacin Injectable; Injection Inforlife
Gabapentin
ANDA #200651		 Gabapentin Tablet; Oral Aurobindo Pharma Ltd
Gabapentin
ANDA #200651		 Gabapentin Tablet; Oral Aurobindo Pharma Ltd
Lamotrigine
ANDA #204499		 Lamotrigine Tablet; Oral Ipca Labs
Gabapentin
ANDA #209306		 Gabapentin Tablet; Oral Lupin Ltd
Gabapentin
ANDA #209306		 Gabapentin Tablet; Oral Lupin Ltd
Enzalutamide
ANDA #209667		 Enzalutamide Capsule; Oral Zydus Pharms
Pomalidomide
ANDA #210236		 Pomalidomide Capsule; Oral Hetero Labs Ltd V
Bafiertam
NDA #210296		 Monomethyl Fumarate Capsule, Delayed Release; Oral Banner Life Sciences
Leflunomide
ANDA #212308		 Leflunomide Tablet; Oral Zydus Lifesciences
Clobazam
ANDA #212398		 Clobazam Tablet; Oral Accord Hlthcare
Leflunomide
ANDA #213652		 Leflunomide Tablet; Oral Aurobindo Pharma
Lumryz
NDA #214755		 Sodium Oxybate For Suspension, Extended Release; Oral Avadel Cns
Aminocaproic Acid
ANDA #215100		 Aminocaproic Acid Solution; Oral Msn
Cobenfy
NDA #216158		 Xanomeline Tartrate;Trospium Chloride Capsule; Oral Bristol-Myers Squibb
Gabapentin
ANDA #217682		 Gabapentin Solution; Oral Annora Pharma
Gabapentin
ANDA #217682		 Gabapentin Solution; Oral Annora Pharma
Mycophenolate Mofetil
ANDA #218227		 Mycophenolate Mofetil For Suspension; Oral Aurobindo Pharma Ltd
Paliperidone
ANDA #218330		 Paliperidone Tablet, Extended Release; Oral Alembic
Amantadine Hydrochloride
ANDA #218598		 Amantadine Hydrochloride Tablet; Oral Zhejiang Jutai Pharm
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