Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves Teva Methylphenidate Hydrochloride ER Capsules (ANDA 077707)
FDA has approved Teva Pharm’s methylphenidate hydrochloride extended‑release capsules in 10 mg, 20 mg and 30 mg strengths under ANDA 077707.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Zenara’s Aminocaproic Acid Injection (ANDA215374)
The FDA has granted approval for Zenara’s aminocaproic acid injectable (250 mg/mL) under ANDA215374, classified as a prescription product.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Assigns NDA 214937 for Helium Inhalation Product by Westair Gases
The FDA has listed NDA 214937 for a prescription helium inhalation gas (HELIUM, USP) submitted by Westair Gases & Equipment Inc., with submission documents dated June‑July 2020.
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 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 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 11, 2026•1 min read
Guro‑gu Pharmaceutical Association Collects Inappropriate Telemedicine Prescription Cases Ahead of Dec 24 Rollout
Guro‑gu Pharmaceutical Association is gathering reports of inappropriate telemedicine prescriptions from pharmacies ahead of the Dec 24 rollout to aid system improvement.
Regulatory Updates
Sep 11, 2026•1 min read
FDA approves KAZANO alogliptin/metformin tablets (NDA 203414)
The FDA has approved the prescription oral tablet KAZANO, containing alogliptin benzoate and metformin hydrochloride, under NDA 203414.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Alkem Labs Triamcinolone Acetonide Creams (ANDA207651)
FDA has approved Alkem Labs Ltd's ANDA207651 for three prescription topical creams containing triaccinolone acetonide at 0.025%, 0.1% and 0.5% strengths.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves LEUCOVORIN CALCIUM (ANDA207241)
The FDA has granted approval for LEUCOVORIN CALCIUM (application ANDA207241) manufactured by Fresenius Kabi USA for prescription use.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves IMPAX Labs' ACARBOSE Oral Tablets (ANDA 078441)
FDA granted approval for IMPAX Labs' ANDA 078441, authorizing prescription oral tablets of ACARBOSE in 25 mg, 50 mg, and 100 mg strengths.