CDER New: 5/21/2026

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 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
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
Esomeprazole Magnesium
ANDA #217264
Esomeprazole Magnesium Capsule, Delayed Release; Oral SUPPL-4 Marksans Pharma Manufacturing (CMC) Approved

May 19, 2026

Drug Name and
Application Number
Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status
Ciprofloxacin
ANDA #076089
Ciprofloxacin Tablet; Oral SUPPL-54 Ivax Sub Teva Pharms Labeling Approved
Ciprofloxacin
ANDA #076089
Ciprofloxacin Tablet; Oral SUPPL-54 Ivax Sub Teva Pharms Labeling Approved
Ciprofloxacin Hydrochloride
ANDA #076089
Ciprofloxacin Hydrochloride Tablet; Oral SUPPL-54 Ivax Sub Teva Pharms Labeling Approved
Ciprofloxacin Hydrochloride
ANDA #076089
Ciprofloxacin Hydrochloride Tablet; Oral SUPPL-54 Ivax Sub Teva Pharms Labeling Approved
Lurasidone Hydrochloride
ANDA #208002
Lurasidone Hydrochloride Tablet; Oral SUPPL-9 Amneal Pharms Co Labeling Approved
Lurasidone Hydrochloride
ANDA #208002
Lurasidone Hydrochloride Tablet; Oral SUPPL-9 Amneal Pharms Co Labeling Approved
Macitentan
ANDA #211026
Macitentan Tablet; Oral SUPPL-1 Seasons Biotech Labeling Approved
Macitentan
ANDA #211026
Macitentan Tablet; Oral SUPPL-1 Seasons Biotech Labeling Approved
Macitentan
ANDA #211026
Macitentan Tablet; Oral SUPPL-1 Seasons Biotech Labeling Approved
Linaclotide
ANDA #211255
Linaclotide Capsule; Oral ORIG-1 Actavis Labs Fl Inc   Tentative Approval
Mirtazapine
ANDA #220104
Mirtazapine Tablet; Oral ORIG-1 Micro Labs   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