Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Eli Lilly's Humulin R & KwikPen Insulin (BLA018780)
The FDA has approved Eli Lilly’s Humulin R injectable insulin products, including OTC and prescription formulations, under application BLA018780.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA090007 for Generic Gabapentin Capsules
FDA has approved ANDA090007 for generic gabapentin oral capsules in 100 mg, 300 mg, and 400 mg strengths, manufactured by Time Cap Laboratories, Bi‑Coastal Pharma, and Marksans Pharma.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Aurobindo Pharma’s Generic EMTRICITABINE (ANDA 079188)
The FDA has approved Aurobindo Pharma’s oral 200 mg EMTRICITABINE capsule under ANDA 079188, confirming its prescription status.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Hikma Phenytoin Sodium Injection (ANDA 084307)
FDA has approved ANDA 084307 for Hikma Pharmaceuticals' generic phenytoin sodium injectable, available for intramuscular and intravenous use with multiple NDC listings.
Regulatory Updates
Sep 15, 2026•1 min read
FDA approves NDA 017830 for Lodosyn (carbidopa) oral tablets
The FDA granted approval for NDA 017830, authorizing the prescription oral tablet Lodosyn (carbidopa) from Bausch Health US and Oceanside Pharmaceuticals.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves BEL MAR Testosterone Propionate Injection (ANDA080741)
The FDA approved ANDA080741 for BEL MAR's Testosterone Propionate injectable, a discontinued product, on Dec 3, 1973.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves INDIUM DTPA IN 111 (NDA 017707) for Intrathecal Diagnostic Use
The FDA has approved INDIUM DTPA IN 111 (NDA 017707), a radiopharmaceutical for intrathecal diagnostic imaging, manufactured by Medi‑Physics/GE Healthcare.
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Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA086148 for Amitriptyline Hydrochloride 150 mg Oral Tablet
The FDA has approved application ANDA086148 submitted by Roxane for a 150 mg oral tablet of amitriptyline hydrochloride, now listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Bausch & Lomb OFLOXACIN Ophthalmic Solution (ANDA 076622)
The FDA granted approval for Bausch & Lomb's OFLOXACIN 0.3% ophthalmic solution (prescription) under ANDA 076622, originally approved in May 2004 with a labeling update in 2020.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ZADITOR Ophthalmic OTC Solution (ANDA077200)
FDA has approved ZADITOR, an over‑the‑counter ophthalmic solution containing 0.025% ketotifen fumarate (application ANDA077200).
Regulatory Updates
Sep 14, 2026•1 min read
Takeda's Orexin Agonist Orzeyful Receives FDA Approval, Targets Narcolepsy and Beyond
Takeda secured FDA clearance for Orzeyful, the first orexin‑based therapy for type‑1 narcolepsy, and experts see potential expansion into arousal, cognition and fatigue treatments.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA089706 for Hydrocortisone 1% Cream – Discontinued
The FDA approved ANDA089706 for a topical hydrocortisone 1% cream submitted by NASKA. The product is listed as discontinued.