CDER New: 5/26/2026

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
  • Drug Firm Annual Registration Status Download File
  • National Drug Code Directory
  • NDC Unfinished Drugs Excluded Database File
  • NDC Database Excluded Packages and Products
  • Wholesale Distributor and Third-Party Logistics Providers Reporting
  • Drug Establishments Current Registration Site
  • Drugs@FDA Data Files 

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 22, 2026

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Fintepla
NDA #212102
Fenfluramine Hydrochloride Solution; Oral SUPPL-18 Ucb Inc REMS Approved
Differin Epiduo Acne Gel (Adapalene and Benzoyl Peroxide)
NDA #220736
Adapalene, Benzoyl Peroxide Gel ORIG-1 Galderma Laboratories, L.P Type 8 - Partial Rx to OTC Switch Approved
Tofidence
BLA #761354
Tocilizumab-Bavi Injectable; Injection SUPPL-9 Biogen Ma   Approved
Tofidence
BLA #761354
Tocilizumab-Bavi Injectable; Injection SUPPL-9 Biogen Ma   Approved
Datroway
BLA #761394
Datopotamab Deruxtecan-Dlnk Injectable; Iv (Infusion) SUPPL-3 Daiichi Sankyo Inc Efficacy Approved
Hepcludex
BLA #761468
Bulevirtide-Gmod Injection; Powder,For Solution ORIG-1 Gilead Sciences Inc Type 1 - New Molecular Entity Approved

May 21, 2026

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Linzess
NDA #202811
Linaclotide Capsule; Oral SUPPL-23 Abbvie Efficacy Approved
Biktarvy
NDA #210251
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Tablet; Oral SUPPL-26 Gilead Sciences Inc Manufacturing (CMC) Approved
Dapagliflozin and Metformin Hydrochloride
ANDA #211491
Dapagliflozin; Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Sun Pharm Manufacturing (CMC) Approved
Dapagliflozin and Metformin Hydrochloride
ANDA #211491
Dapagliflozin; Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Sun Pharm 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   Tentative Approval
Clonazepam
ANDA #216988
Clonazepam Tablet, Orally Disintegrating; Oral ORIG-1 Rubicon Research   Approved
Sitagliptin and Metformin Hydrochloride
ANDA #218405
Sitagliptin, Metformin Hydrochloride Tablet ORIG-1 Mankind Pharma Ltd   Tentative Approval
Lacosamide
ANDA #220366
Lacosamide Solution; Oral ORIG-1 Steranco Hlthcare   Approved
Nyvepria
BLA #761111
Pegfilgrastim-Apgf Injectable; Injection SUPPL-10 Hospira Inc Labeling Approved
Tyenne
BLA #761275
Tocilizumab-Aazg Injectable; Intravenous SUPPL-22 Fresenius Kabi Usa Labeling Approved
feedtwitterfacebookyoutubeflickr

Manage Subscriptions  |  Unsubscribe All  |  Help


This email was sent to Esdek@podam.pl using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration · 
10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA
GovDelivery logo