Regulatory Updates

FDA has approved Teva Pharm’s methylphenidate hydrochloride extended‑release capsules in 10 mg, 20 mg and 30 mg strengths under ANDA 077707.

The FDA has approved Teva Pharmaceuticals’ generic olanzapine oral tablets (5‑20 mg) under ANDA 077243, with several labeling supplements filed since 2014.

The FDA has approved ANDA 076942 for a prescription 2% ketoconazole shampoo, marketed by Cosette Pharmaceuticals. Submission history includes labeling updates through 2020.

The FDA has approved ANDA214528 for Ephedrine Sulfate injection, a 50 mg/mL intravenous solution manufactured by Sagent Pharmaceuticals.

The U.S. FDA has approved Priovant Therapeutics' dual TYK2/JAK1 inhibitor brepocitinib, branded Lisraya, as a once‑daily oral treatment for adult dermatomyositis, marking the first targeted therapy for this steroid‑dependent disease.

The FDA granted approval for NDA020675 covering URSO 250 (250 mg) and URSO FORTE (500 mg) ursodiol tablets from Allergan, though both products are now listed as discontinued.

FDA has approved Hospira's aztreonam injectable (1 g and 2 g vials) for intramuscular and intravenous use under ANDA206517.

The FDA has approved application ANDA205336 for a prescription diphenhydramine hydrochloride injectable (50 mg/mL) product marketed by Avet Lifesciences for IM and IV use.

The FDA has granted approval for Sun Pharmaceutical Industries’ Zolpidem Tartrate extended‑release tablets (6.25 mg and 12.5 mg) under ANDA 204170.

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.

FDA approves Sevelamer Carbonate oral suspension (ANDA207291), a prescription product available in 800 mg and 2.4 g packets, sponsored by Macleods Pharms.

The FDA approved ANDA206918 for Fondaparinux Sodium subcutaneous solutions, manufactured by Eugia Pharma, with multiple dosage strengths and NDC codes.