규제 업데이트

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

FDA has approved the ANDA206097 application for Zydus Pharm's prescription LINEZOLID 600 mg oral tablet, with labeling approvals up to July 2026.

The FDA issued a standard review tentative approval (TA) for ANDA205757 submitted by Pharmascience Inc., status dated Feb 15, 2019.

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.

FDA records indicate CAPLIN's paricalcitol intravenous solutions (product numbers 001‑003) are discontinued, with original ANDA204910 approved in 2016 and labeling updates in 2024.

FDA granted approval for ANDA204552, an oral extended‑release capsule combining 25 mg aspirin and 200 mg dipyridamole, sponsored by Chartwell Molecular.

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

Lawyer Kim Ki-ung introduced a bill to amend the Emergency Medical Act, aiming to increase night and holiday pediatric services and address gaps in non‑capital and rural areas.

The Ministry of Health and Welfare announced on September 1, 2026 that Kim Eun‑young has been transferred to the position of Basic Living Security Department Manager.

FDA records show four discontinued oral tablet strengths of Clozapine and several approved REMS and labeling submissions spanning 2015‑2025.

The FDA has approved the prescription oral tablet KAZANO, containing alogliptin benzoate and metformin hydrochloride, under NDA 203414.

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.