Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Mylan Sumatriptan Succinate Tablets (ANDA 077744)
The FDA has approved Mylan Pharmaceuticals' sumatriptan succinate tablets (25 mg, 50 mg, 100 mg) under ANDA 077744, with multiple labeling submissions recorded.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Irbesartan/Hydrochlorothiazide Combination Tablets (ANDA 077446)
The FDA has approved two prescription oral tablets combining irbesartan and hydrochlorothiazide under ANDA 077446, with multiple labeling supplements approved.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA076568 for Nicotine Polacrilex OTC Chewing Gum
The FDA has approved ANDA076568 for Nicotine Polacrilex chewing gum, an over‑the‑counter nicotine replacement product available in 4 mg and 2 mg strengths.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 077139 for Teva’s Intravenous Carboplatin Injectable Products
The FDA has approved ANDA 077139 for Teva Pharm USA’s carboplatin injectable products, with multiple supplemental approvals covering labeling and manufacturing.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA076850 for Terconazole Vaginal Suppository
FDA granted approval (ANDA076850) for Fougera Pharms' terconazole 80 mg vaginal suppository, now listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Vincristine Sulfate Injection (ANDA076296) by Fresenius Kabi USA
The FDA approved ANDA076296 for a Vincristine Sulfate injectable (1 mg/mL) submitted by Fresenius Kabi USA. The product is listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Multiple Submissions for Discontinued Ophthalmic Product Isopto Cetamide
FDA records show Isopto Cetamide ophthalmic solution (15% sulfacetamide sodium) received several approved manufacturing and labeling submissions from 1971 to 2000; the product is now discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Issues Tentative Approval for Atomoxetine Hydrochloride Capsules (ANDA078940)
The FDA has granted tentative approval for six oral capsule strengths of atomoxetine hydrochloride under ANDA078940, sponsored by Actavis Elizabeth.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Buprenorphine ANDA078633 Sublingual Tablets
FDA has approved an ANDA for buprenorphine sublingual tablets (2 mg and 8 mg) from Hikma Pharmaceuticals USA Inc., with associated labeling and REMS submissions.
Regulatory Updates
Sep 21, 2026•1 min read
FDA Grants Accelerated Approval to AstraZeneca’s Oral SERD Etcamah for HR‑Positive/HER2‑Negative Breast Cancer
The US FDA approved AstraZeneca’s oral SERD camizestrant, branded Etcamah, for HR‑positive/HER2‑negative breast cancer patients with ESR1‑mutated ctDNA detected before radiographic progression, based on the Phase 3 SERENA‑6 trial.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Sandoz ALPHAZINE (phendimetrazine) ANDA085034
The FDA approved ANDA085034 for ALPHAZINE, a 35 mg phendimetrazine tartrate oral tablet by Sandoz, with original and supplemental approvals spanning 1978‑1991.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA 084553 for COMPOUND 65 Oral Capsule
FDA approved ANDA 084553 for COMPOUND 65, an oral capsule containing aspirin 389 mg, caffeine 32.4 mg, and propoxyphene HCl 65 mg; sponsor ALRA; product listed as discontinued.