GXPNews - FDA News & Announcements October 21 - October 25, 2024
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Whats New with CDER
Drug News and Events

October 24, 2024

October 22, 2024

October 21, 2024

October 17, 2024
CDER Meetings and Conferences
01/07/2025 GMP QMS FREE 8-hour Training Hosted by The Auditing Group
12/10/2024 FDA Clinical Investigator Training Course (CITC) 2024
12/04/2024 Navigating the Transition to Low Global Warming Potential Propellants
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
11/07/2024 Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation
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 Opportunities to Improve Dose-Finding and Optimization for Rare Disease Drug Development
10/29/2024 October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee
10/28/2024 2024 DIA/FDA Oligonucleotide-Based Therapeutics Conference
 
Dietary Supplements

Dietary Supplements

Featured Links

Applications & Submissions

Related Resources
 
Whats New with CDRH
Medical Device News and Events

October 25, 2024

October 24, 2024

October 23, 2024

October 22, 2024

October 21, 2024

October 18, 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
10/30/2024 Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
 
Whats New with CBER Center for Biologic Evaluation and Research
10/25/2024 OTP Town Hall: Best Practices for Regulatory Interactions with OTP
10/24/2024 CBER-Regulated Products: Current Shortages
Albumin (Human)-kjda
10/24/2024 CBER-Regulated Products: Current Shortages
Immune Globulin Intravenous (Human)
10/24/2024 Vaccines and Related Biological Products Advisory Committee December 12, 2024 Meeting Announcement
10/23/2024 October 22, 2024 Approval Letter - ABRYSVO (STN125769/225)
10/23/2024 Meeting 2: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Diseases
10/22/2024 September 27, 2024 Clinical Review Memo - VISTASEAL
10/22/2024 September 27, 2024 Statistical Review Memo - VISTASEAL
10/22/2024 October 18, 2024 Approval Letter - JYNNEOS
10/22/2024 Drug Interaction Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry
10/21/2024 Extension of the Expiration Date for 10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP) Lot 5859955 through April 1, 2025 and 10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) Lot 6040410 through September 1, 2025
10/21/2024 October 18, 2024 Approval Letter - AREPANRIX
10/18/2024 Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry
10/18/2024 CBER-Regulated Products: Current Shortages
plasminogen, human-tvmh
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 21 October - NONE
  • Tueday 22 October - 21 CFR Part 1308 (DEA)
  • Wednesday 23 October - NONE
  • Thursday 24 October - NONE
  • Friday 25 October - 21 CFR Part 1308 (DEA)
Monday 21 October 2024

Notices

Determination of Regulatory Review Period for Purposes of Patent Extension; Pascal Precision Transcatheter Valve Repair System

Determination of Regulatory Review Period for Purposes of Patent Extension; Gore Tag Thoracic Branch Endoprosthesis

Determination of Regulatory Review Period for Purposes of Patent Extension; Vyndaqel

Determination of Regulatory Review Period for Purposes of Patent Extension; Vyndamax

Tuesday 22 October 2024

Drug Enforcement Administration (DEA)

Rules and Regulations - 21 CFR Part 1308 (DEA)

Schedules of Controlled Substances: Placement of Ethylphenidate in Schedule I

Food and Drug Administration (FDA)

Notices

Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period

Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Availability

Wednesday 23 October 2024

NONE

 
Thursday 24 October 2024

Rules and Regulations - Guidance, Not Regulations

Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Guidance for Industry; Availability

Notices

Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales and Distribution

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Friday 25 October 2024

Drug Enforcement Administration (DEA) - 21 CFR Part 1308

Rules and Regulations - 21 CFR Part 1308 (DEA)

Schedules of Controlled Substances: Placement of Butonitazene, Flunitazene, and Metodesnitazene Substances in Schedule I

Food and Drug Administration (FDA)

Notices

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

Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Guidance for Industry; Availability

Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List

 
 
 
 
 
 
 
 
 
 
 

Drug Enforcement Administration (DEA)

Food and Drug Administration (FDA)

Tissue and Cell Key Resources
 

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Standard Sterile Product
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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 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook

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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 25, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Orlynvah
NDA #213972		 Sulopenem Etzadroxil;Probenecid Tablet ORIG-1 Iterum Therapeutics Us Ltd Type 1 - New Molecular Entity and Type 4 - New Combination Approved

October 24, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Heparin Sodium
NDA #000552		 Heparin Sodium Injectable; Injection Aspen Global Inc
Liquaemin Lock Flush
NDA #000552		 Heparin Sodium Injectable; Injection Aspen Global Inc
Liquaemin Sodium
NDA #000552		 Heparin Sodium Injectable; Injection Aspen Global Inc
Liquaemin Sodium Preservative Free
NDA #000552		 Heparin Sodium Injectable; Injection Aspen Global Inc
Heparin Lock Flush
NDA #017007		 Heparin Sodium Injectable; Injection Hikma
Heparin Sodium
NDA #017007		 Heparin Sodium Injectable; Injection Hikma
Heparin Sodium
NDA #017029		 Heparin Sodium Injectable; Injection Fresenius Kabi Usa
Heparin Sodium 20,000 Units In Dextrose 5%
NDA #017029		 Heparin Sodium Injectable; Injection Fresenius Kabi Usa
Heparin Sodium 25,000 Units In Dextrose 5%
NDA #017029		 Heparin Sodium Injectable; Injection Fresenius Kabi Usa
Heparin Sodium 25,000 Units In Sodium Chloride 0.45%
NDA #017029		 Heparin Sodium Injectable; Injection Fresenius Kabi Usa
Heparin Sodium In Plastic Container
NDA #017029		 Heparin Sodium Injectable; Injection Fresenius Kabi Usa
Heparin Sodium Preservative Free
NDA #017029		 Heparin Sodium Injectable; Injection Fresenius Kabi Usa
Heparin Sodium
NDA #017037		 Heparin Sodium Injectable; Injection Hikma
Heparin Lock Flush
NDA #017064		 Heparin Sodium Injectable; Injection Dr Reddys
Heparin Sodium
NDA #017064		 Heparin Sodium Injectable; Injection Dr Reddys
Heparin Sodium
NDA #017651		 Heparin Sodium Injectable; Injection Fresenius Kabi Usa
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
Fragmin
NDA #020287		 Dalteparin Sodium Injectable; Injection Pfizer
Fragmin
NDA #020287		 Dalteparin Sodium Injectable; Subcutaneous Pfizer
Flonase Sensimist Allergy Relief
NDA #022051		 Fluticasone Furoate Spray, Metered; Nasal Haleon Us Holdings
Heparin Sodium
NDA #201370		 Heparin Sodium Injectable; Injection Pfizer
Heparin Sodium Preservative Free
NDA #201370		 Heparin Sodium Injectable; Injection Pfizer
Flonase Allergy Relief
NDA #205434		 Fluticasone Propionate Spray, Metered; Nasal Haleon Us Holdings
Inmazeb
BLA #761169		 Atoltivimab; Odesivimab; Maftivimab Solution; Injection Regeneron Pharmaceuticals
Jubbonti
BLA #761362		 Denosumab-Bbdz Injectable; Subcutaneous Sandoz Inc
Wyost
BLA #761362		 Denosumab-Bbdz Injectable; Subcutaneous Sandoz Inc

October 23, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075351		 Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral Strides Pharma
Butalbital, Aspirin, Caffeine, and Codeine Phosphate
ANDA #075351		 Aspirin; Butalbital; Caffeine; Codeine Phosphate Capsule; Oral Strides Pharma
Bupropion Hydrochloride
ANDA #077715		 Bupropion Hydrochloride Tablet, Extended Release; Oral Actavis Labs Fl Inc
Bupropion Hydrochloride
ANDA #077715		 Bupropion Hydrochloride Tablet, Extended Release; Oral Actavis Labs Fl Inc
Topiramate
ANDA #078235		 Topiramate Tablet; Oral Zydus Pharms Usa Inc
Topiramate
ANDA #078235		 Topiramate Tablet; Oral Zydus Pharms Usa Inc
Nevirapine
ANDA #078584		 Nevirapine Tablet; Oral Hetero Labs Ltd Iii
Nevirapine
ANDA #078584		 Nevirapine Tablet; Oral Hetero Labs Ltd Iii
Alfuzosin Hydrochloride
ANDA #079057		 Alfuzosin Hydrochloride Tablet, Extended Release; Oral Sun Pharm
Alfuzosin Hydrochloride
ANDA #079057		 Alfuzosin Hydrochloride Tablet, Extended Release; Oral Sun Pharm
Purixan
NDA #205919		 Mercaptopurine Suspension; Oral Nova Labs Ltd
Purixan
NDA #205919		 Mercaptopurine Suspension; Oral Nova Labs Ltd
Esomeprazole Magnesium
ANDA #208511		 Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral Macleods Pharms Ltd
Jylamvo
NDA #212479		 Methotrexate Solution; Oral Shorla
Jylamvo
NDA #212479		 Methotrexate Solution; Oral Shorla
Vigabatrin
ANDA #214425		 Vigabatrin For Solution; Oral Accord Hlthcare
Deferasirox
ANDA #214650		 Deferasirox Granule; Oral Msn
Estradiol
ANDA #217882		 Estradiol Gel, Metered; Transdermal Novitium Pharma

October 22, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Zarxio
BLA #125553		 Filgrastim-Sndz Injectable; Injection Sandoz Inc
Zarxio
BLA #125553		 Filgrastim-Sndz Injectable; Injection Sandoz Inc
Mycophenolate Mofetil
ANDA #207022		 Mycophenolate Mofetil Capsule; Oral Hetero Labs Ltd V
Mycophenolate Mofetil
ANDA #208119		 Mycophenolate Mofetil Tablet; Oral Hetero Labs Ltd V
Icatibant Acetate
ANDA #213521		 Icatibant Acetate Injectable; Subcutaneous Eugia Pharma
Icatibant Acetate
ANDA #213521		 Icatibant Acetate Injectable; Subcutaneous Eugia Pharma
Carbamazepine
ANDA #215664		 Carbamazepine Tablet, Extended Release; Oral Osmotica Pharm Us
Formoterol Fumarate
ANDA #216426		 Formoterol Fumarate Solution; Inhalation Lexenpharm

October 21, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Omeprazole Magnesium
ANDA #206582		 Omeprazole Magnesium Tablet, Delayed Release; Oral P and L
Omeprazole Magnesium
ANDA #206582		 Omeprazole Magnesium Tablet, Delayed Release; Oral P and L
Brexpiprazole
ANDA #213587		 Brexpiprazole Tablet; Oral Prinston Pharma Inc
Orladeyo
NDA #214094		 Berotralstat Hydrochloride Capsule; Oral Biocryst
Levalbuterol Hydrochloride
ANDA #218770		 Levalbuterol Hydrochloride Solution; Inhalation Mankind Pharma

October 18, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Diflunisal
ANDA #073673		 Diflunisal Tablet; Oral Teva
Diflunisal
ANDA #073673		 Diflunisal Tablet; Oral Teva
Diflunisal
ANDA #073673		 Diflunisal Tablet; Oral Teva
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Atazanavir Sulfate
ANDA #091673		 Atazanavir Sulfate Capsule; Oral Teva Pharms Usa
Botox
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox Cosmetic
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox Cosmetic
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox Cosmetic
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox Cosmetic
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox Cosmetic
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox Cosmetic
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Botox Cosmetic
BLA #103000		 Onabotulinumtoxina Vial; Single-Use Allergan
Labetalol Hydrochloride
ANDA #209603		 Labetalol Hydrochloride Tablet; Oral Appco
Metformin Hydrochloride
ANDA #209694		 Metformin Hydrochloride Tablet, Extended Release; Oral Aurobindo Pharma
Fosaprepitant Dimeglumine
ANDA #212309		 Fosaprepitant Dimeglumine Powder; Intravenous Be Pharms
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate
ANDA #212903		 Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate Solution; Oral Annora Pharma
Orgovyx
NDA #214621		 Relugolix Tablet; Oral Sumitomo Pharma
Xromi
NDA #216593		 Hydroxyurea Solution; Oral Nova Labs Ltd
Lasix Onyu
NDA #217294		 Furosemide Injection Injection; Solution Sq Innovation, Inc
Zepbound
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound (Autoinjector)
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound (Autoinjector)
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound (Autoinjector)
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound (Autoinjector)
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound (Autoinjector)
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound (Autoinjector)
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound (Autoinjector)
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Zepbound (Autoinjector)
NDA #217806		 Tirzepatide Solution; Subcutaneous Eli Lilly and Co
Diltiazem Hydrochloride
ANDA #218587		 Diltiazem Hydrochloride Capsule, Extended Release; Oral Alembic
Selarsdi
BLA #761343		 Ustekinumab-Aekn Injectable; Injection Alvotech Usa Inc
Selarsdi
BLA #761343		 Ustekinumab-Aekn Injectable; Injection Alvotech Usa Inc
Selarsdi
BLA #761343		 Ustekinumab-Aekn Injectable; Injection Alvotech Usa Inc
Selarsdi
BLA #761343		 Ustekinumab-Aekn Injectable; Injection Alvotech Usa Inc
Selarsdi
BLA #761343		 Ustekinumab-Aekn Injectable; Injection Alvotech Usa Inc
Selarsdi
BLA #761343		 Ustekinumab-Aekn Injectable; Injection Alvotech Usa Inc
Selarsdi
BLA #761343		 Ustekinumab-Aekn Injectable; Injection Alvotech Usa Inc
Vyloy
BLA #761365		 Zolbetuximab-Clzb Injectable; Injection Astellas

October 17, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Clorazepate Dipotassium
ANDA #075731		 Clorazepate Dipotassium Tablet; Oral Taro
Clorazepate Dipotassium
ANDA #075731		 Clorazepate Dipotassium Tablet; Oral Taro
Clorazepate Dipotassium
ANDA #075731		 Clorazepate Dipotassium Tablet; Oral Taro
Clorazepate Dipotassium
ANDA #075731		 Clorazepate Dipotassium Tablet; Oral Taro
Clorazepate Dipotassium
ANDA #075731		 Clorazepate Dipotassium Tablet; Oral Taro
Clorazepate Dipotassium
ANDA #075731		 Clorazepate Dipotassium Tablet; Oral Taro
Oxaprozin
ANDA #075849		 Oxaprozin Tablet; Oral Teva
Oxaprozin
ANDA #075849		 Oxaprozin Tablet; Oral Teva
Oxaprozin
ANDA #075849		 Oxaprozin Tablet; Oral Teva
Oxaprozin
ANDA #075849		 Oxaprozin Tablet; Oral Teva
Oxaprozin
ANDA #075849		 Oxaprozin Tablet; Oral Teva
Oxaprozin
ANDA #075849		 Oxaprozin Tablet; Oral Teva
Propafenone Hydrochloride
ANDA #075938		 Propafenone Hydrochloride Tablet; Oral Strides Pharma
Propafenone Hydrochloride
ANDA #075938		 Propafenone Hydrochloride Tablet; Oral Strides Pharma
Propafenone Hydrochloride
ANDA #075938		 Propafenone Hydrochloride Tablet; Oral Strides Pharma
Propafenone Hydrochloride
ANDA #075938		 Propafenone Hydrochloride Tablet; Oral Strides Pharma
Propafenone Hydrochloride
ANDA #075938		 Propafenone Hydrochloride Tablet; Oral Strides Pharma
Propafenone Hydrochloride
ANDA #075938		 Propafenone Hydrochloride Tablet; Oral Strides Pharma
Rivaroxaban
ANDA #208544		 Rivaroxaban Tablet; Oral Aurobindo Pharma
Mycophenolate Mofetil
ANDA #211272		 Mycophenolate Mofetil For Suspension; Oral Teva Pharms Usa
Mycophenolate Mofetil
ANDA #211272		 Mycophenolate Mofetil For Suspension; Oral Teva Pharms Usa
Fensolvi Kit
NDA #213150		 Leuprolide Acetate Powder; Subcutaneous Tolmar
Leuprolide Acetate
ANDA #217957		 Leuprolide Acetate Solution; Subcutaneous Ubi
Bupropion Hydrochloride
ANDA #218385		 Bupropion Hydrochloride Tablet, Extended Release; Oral Granules
Fluvoxamine Maleate
ANDA #219055		 Fluvoxamine Maleate Capsule, Extended Release; Oral Ajanta Pharma Ltd

October 16, 2024

Drug Name and
Application Number		 Active Ingredient Dosage Form/ Route Company
Rosuvastatin Calcium
ANDA #079170		 Rosuvastatin Calcium Tablet; Oral Aurobindo Pharma Ltd
Sacubitril and Valsartan
ANDA #213728		 Sacubitril; Valsartan Tablet; Oral Macleods Pharms Ltd
Sugammadex
ANDA #214306		 Sugammadex Injectable; Injection Zenara Pharma Private Ltd
Lumryz
NDA #214755		 Sodium Oxybate For Suspension, Extended Release; Oral Avadel Cns
Zinc Chloride
ANDA #216152		 Zinc Chloride Injectable; Injection Somerset
Vyalev
NDA #216962		 Foscarbidopa and Foslevodopa Injection; Solution Abbvie Inc
Ivermectin
ANDA #218324		 Ivermectin Tablet; Oral Senores Pharms
Famotidine
ANDA #218344		 Famotidine For Suspension; Oral Epic Pharma Llc
Fludrocortisone Acetate
ANDA #219251		 Fludrocortisone Acetate Tablet; Oral Zydus
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