CDER New: 5/22/2026

The approvals listed below may not be comprehensive. For the most current information, view the full listing of all approvals at Drugs@FDA.

What's New Related to Drugs

Updated Monday through Friday

  • Current and Resolved Drug Shortages and Discontinuations Reported to FDA
  • Drug Firm Annual Registration Status
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  • Wholesale Distributor and Third-Party Logistics Providers Reporting
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Updated Biweekly

  • Competitive Generic Therapy Approvals

May 20, 2026

  • Webinar: Eco-NAMs Webinar Series | In Silico Approaches to Replace Acute Fish Toxicity

May 15, 2026

  • Alert: FDA warns consumers not to use expired Amazon Basic Care Levonorgestrel 1.5 mg
  • FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
  • FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis
  • Public Notification: Sâm Xương Khớp Ông Tiên may be harmful due to hidden drug ingredients
  • FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease

This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.

May 21, 2026

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-26 Gilead Sciences Inc Manufacturing (CMC) Approved
Argatroban In Sodium Chloride
NDA #212035
Argatroban Solution; Intravenous SUPPL-3 Accord Hlthcare Labeling Approved
Empagliflozin
ANDA #212371
Empagliflozin Tablet ORIG-1 Aurobindo Pharma Limited Labeling Tentative Approval
Sitagliptin and Metformin Hydrochloride
ANDA #218405
Sitagliptin, Metformin Hydrochloride Tablet ORIG-1 Mankind Pharma Ltd Labeling Tentative Approval
Tyenne
BLA #761275
Tocilizumab-Aazg Injectable; Intravenous SUPPL-22 Fresenius Kabi Usa Labeling Approved

May 20, 2026

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Children's Claritin
NDA #021891
Loratadine Tablet, Chewable; Oral SUPPL-47 Bayer Healthcare Llc Labeling Approved
Claritin
NDA #021891
Loratadine Tablet, Chewable; Oral SUPPL-47 Bayer Healthcare Llc Labeling Approved
Brimonidine Tartrate
ANDA #078479
Brimonidine Tartrate Solution/Drops; Ophthalmic SUPPL-6 Apotex Labeling Approved
Brimonidine Tartrate
ANDA #078480
Brimonidine Tartrate Solution/Drops; Ophthalmic SUPPL-5 Apotex Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-30 Acs Dobfar Labeling Approved
Meropenem
ANDA #091404
Meropenem Injectable; Injection SUPPL-32 Acs Dobfar Labeling Approved
Eplerenone
ANDA #208283
Eplerenone Tablet; Oral SUPPL-2 Breckenridge Labeling Approved
Venclexta
NDA #208573
Venetoclax Tablet; Oral SUPPL-32 Abbvie Efficacy Approved
Xyzal Allergy 24hr
NDA #209089
Levocetirizine Dihydrochloride Tablet; Oral SUPPL-10 Chattem Sanofi Labeling Approved
Zoledronic Acid
ANDA #209125
Zoledronic Acid Injectable; Intravenous SUPPL-5 Eugia Pharma Labeling Approved
Zoledronic Acid
ANDA #209125
Zoledronic Acid Injectable; Intravenous SUPPL-5 Eugia Pharma Labeling Approved
Verapamil Hydrochloride
ANDA #211015
Verapamil Hydrochloride Solution; Intravenous SUPPL-16 Somerset Theraps Llc Labeling Approved
Verapamil Hydrochloride
ANDA #211035
Verapamil Hydrochloride Solution; Intravenous SUPPL-1 Somerset Labeling Approved
Verapamil Hydrochloride
ANDA #211035
Verapamil Hydrochloride Solution; Intravenous SUPPL-11 Somerset Labeling Approved
Nebivolol Hydrochloride
ANDA #212682
Nebivolol Hydrochloride Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nebivolol Hydrochloride
ANDA #212682
Nebivolol Hydrochloride Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Nebivolol Hydrochloride
ANDA #212682
Nebivolol Hydrochloride Tablet; Oral SUPPL-3 Prinston Inc Labeling Approved
Levothyroxine Sodium
ANDA #216370
Levothyroxine Sodium Tablet; Oral ORIG-1 Alembic   Approved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #217027
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-15 Granules Labeling Approved
Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate
ANDA #217027
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral SUPPL-15 Granules Labeling Approved
Esomeprazole Magnesium
ANDA #217264
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-4 Marksans Pharma Manufacturing (CMC) Approved
Acalabrutinib
ANDA #220055
Acalabrutinib Tablet ORIG-1 Msn Laboratories Private Limited   Tentative Approval
Tyenne
BLA #761449
Tocilizumab-Aazg Injectable; Subcutaneous SUPPL-6 Fresenius Kabi Usa Labeling Approved
Tyenne
BLA #761449
Tocilizumab-Aazg Injectable; Subcutaneous SUPPL-6 Fresenius Kabi Usa Labeling Approved
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