Regulatory Updates
Sep 12, 2026•1 min read
FDA Expands Mounjaro Use to Reduce Cardiovascular Risk in Type 2 Diabetes
The FDA granted additional approval for Eli Lilly’s Mounjaro (tirzepatide) to lower major cardiovascular events in adults with type 2 diabetes and existing cardiovascular risk, matching Novo Nordisk’s Ozempic indication.
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Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA212957 for Fosaprepitant Dimeglumine (Discontinued Product)
The FDA granted approval (status AP) for ANDA212957 submitted by Chartwell Rx for the intravenous powder Fosaprepitant Dimeglumine, which is listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Aurobindo Pharma’s Pirfenidone Oral Tablets (ANDA 212596)
The FDA has approved Aurobindo Pharma’s pirfenidone tablets (ANDA 212596) for prescription use, available in 267 mg and 801 mg strengths.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves PROCHLORPERAZINE EDISYLATE Injection (ANDA212257)
The FDA has approved the ANDA212257 application for PROCHLORPERAZINE EDISYLATE injectable, manufactured by Somerset Therapeutics, for intramuscular and intravenous use.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA216216 for METOLAZONE Tablets
The FDA has approved application ANDA216216 for METOLAZONE oral tablets in 2.5 mg, 5 mg, and 10 mg strengths, sponsored by NE RX Pharma.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ARTHROTEC (Diclofenac Sodium and Misoprostol)
The FDA has approved NDA020607 for ARTHROTEC, a prescription oral delayed‑release tablet combining diclofenac sodium with misoprostol in 50 mg/0.2 mg and 75 mg/0.2 mg strengths.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA 078408 for Vinorelbine Tartrate Injection by Ebewe Pharma
The FDA approved ANDA 078408 for Vinorelbine Tartrate injectable product from Ebewe Pharma. The product is listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA approves Bedford ciprofloxacin injection ANDA078114
FDA issued an approval letter for Bedford's ANDA078114 covering ciprofloxacin injection products (200 mg/100 mL and 400 mg/200 mL), both listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Discontinues TOLECTIN Oral Tolmetin Products (NDA017628)
The FDA has marked the oral Tolmetin tablets TOLECTIN 600 mg and TOLECTIN 200 mg as discontinued, with a record of multiple manufacturing and labeling submissions from 1979 to 1993.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves RETIN-A (Tretinoin) Topical Gel – NDA 017579
The FDA has approved NDA017579 for RETIN-A, a prescription 0.025% tretinoin topical gel marketed by Bausch Health US and Mylan Pharmaceuticals.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves NIPRIDE (Sodium Nitroprusside) Injection – NDA 017546
FDA approved Roche's injectable NIPRIDE (sodium nitroprusside 50 mg/vial) under NDA 017546 in 1974; the product is now discontinued after multiple labeling updates.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA076914 for Tramadol Hydrochloride and Acetaminophen Tablet
The FDA has approved ANDA076914 for a discontinued oral tablet combining 37.5 mg tramadol hydrochloride and 325 mg acetaminophen, submitted by Graviti Pharms.