Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Apotex’s Albuterol Sulfate Inhalation Solution (ANDA 076391)
The FDA granted approval for Apotex Inc.’s ANDA 076391, an inhalation solution of albuterol sulfate, with original approval in 2003 and a labeling supplement in 2017.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Sodium Chloride Injection (NDA018090)
The FDA has approved NDA018090 for Sodium Chloride 0.45% injectable, manufactured by ICU Medical Inc.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA090018 for ZoleDRonic Acid Injectable (Discontinued)
Sun Pharma Global received FDA approval (ANDA090018) for a 4 mg/vial intravenous ZoleDRonic Acid injectable, currently listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA077850 for Nicotine Polacrilex Buccal Gum
FDA granted approval for ANDA077850, a generic nicotine polacrilex buccal gum (4 mg base) by IVAX Sub Teva Pharms, with labeling supplements approved in 2012 and 2013.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Revolution Medicines' Daraxonrasib (Rasonque) for Metastatic Pancreatic Cancer
The FDA granted accelerated approval to Revolution Medicines' oral RAS inhibitor daraxonrasib, branded Rasonque, for metastatic pancreatic adenocarcinoma patients with prior therapy, after positive ASCO data.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Sandoz Ondansetron Hydrochloride Preservative‑Free Injection (ANDA 077551)
Sandoz received FDA approval for a generic ondansetron hydrochloride injection (preservative‑free) under ANDA 077551, with original and supplemental labeling approvals dating from 2007 to 2015.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077248 for Pilocarpine Hydrochloride Oral Tablets
The FDA has granted approval for ANDA077248, an oral tablet formulation of pilocarpine hydrochloride (5 mg and 7.5 mg) manufactured by Impax Labs and Amneal Pharmaceuticals.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Watson Labs Ciprofloxacin Ophthalmic Solution (ANDA 076673)
FDA granted approval for Watson Labs' ciprofloxacin hydrochloride ophthalmic solution (ANDA 076673), a prescription eye drop approved in 2005 with a labeling update in 2007.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves GYNE-LOTRIMIN Vaginal Cream (Clotrimazole 1%)
The FDA approved GYNE-LOTRIMIN, a clotrimazole 1% vaginal cream, in 1978 and issued multiple manufacturing and labeling supplements thereafter; the product is now discontinued for non‑safety reasons.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA080693 for Hydrocortisone 1% Topical Cream
The FDA has approved application ANDA080693 for a prescription 1% hydrocortisone topical cream marketed as HYDROCORTISONE by Fougera Pharm Inc.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA076316 for Sodium Chloride 0.9% Injection
The FDA has granted approval for ANDA076316, a prescription injectable sodium chloride 0.9% solution in a plastic container, submitted by GVS TM.
Regulatory Updates
Sep 6, 2026•1 min read
Roche and Eli Lilly's Elecsys pTau217 Blood Test Receives FDA Approval
Roche and Eli Lilly's Elecsys pTau217 blood test for Alzheimer’s received FDA clearance, measuring phosphorylated tau 217 to aid diagnosis and exclusion.