Regulatorische Updates

The FDA has granted approval for Lannett’s generic VELTANE oral tablet containing 4 mg brompheniramine maleate (ANDA 084088).

The Ministry of Health and Welfare allocated 13.4 billion KRW for drug addiction treatment in the 2027 budget, a 38% rise from the previous year.

GC Green Cross received MFDS IND approval to start Phase 2/3 trials of its high‑immunogenicity influenza vaccine candidate GC3114B in adults 65+, targeting domestic self‑sufficiency and future NIP inclusion.

FDA approved ANDA083457 for MK Labs' oral Vitamin A capsule products, both listed as discontinued, with details on dosage strengths and submission date.

The FDA granted approval for labeling and manufacturing submissions for ANDA081095, a discontinued oral capsule combining acetaminophen, aspirin, and codeine phosphate, sponsored by MIKART.

The FDA entry ANDA080493 shows Purepac Pharm's oral CORTISONE ACETATE 25 mg tablet is listed as discontinued.

The FDA has approved Aurobindo Pharma’s oral 200 mg EMTRICITABINE capsule under ANDA 079188, confirming its prescription status.

The FDA approved ANDA 078873 for Teva’s methylphenidate hydrochloride extended‑release capsules (40 mg, 50 mg, 60 mg). All listed products are currently discontinued.

The FDA has approved a series of manufacturing (CMC) and labeling submissions for SLO‑BID, an oral extended‑release theophylline capsule, now listed as discontinued.

FDA records show ASCOT's oral tablet containing diphenoxylate hydrochloride 2.5 mg and atropine sulfate 0.025 mg is listed as discontinued under ANDA 087934.

The FDA approved application ANDA087564 for Sun Pharm Industries' oral tablet Isosorbide Dinitrate 30 mg, listed with a discontinued marketing status.

FDA has approved ANDA087129 for a 4 mg oral tablet of Cyproheptadine Hydrochloride, sponsored by Strides Pharma Intl, with a history of labeling and manufacturing supplements.