規制動向

The FDA has listed the oral prednisone 5 mg tablet (product 001) from sponsor HALSEY as discontinued under application ANDA080300.

The Korean Pharmacists Association continued its 344‑day relay rally, urging swift amendment of the pharmacist law to clarify license scopes for pharmacists and herbal pharmacists.

FDA has approved Oxford Pharm's abbreviated new drug application for generic simvastatin tablets in five strengths, all prescription oral products.

FDA granted approval for IMPAX Labs' ANDA 078441, authorizing prescription oral tablets of ACARBOSE in 25 mg, 50 mg, and 100 mg strengths.

The FDA records show that Watson Labs' potassium chloride injectable (3 mEq/mL) under ANDA 086210 is listed with a discontinued marketing status.

The FDA has approved ANDA085790 for an oral 100 mg Isoniazid tablet submitted by Watson Labs. The product is currently listed as discontinued.

The FDA granted approval (ANDA 086892) for Lederle's oral capsule containing 5 mg chlordiazepoxide hydrochloride, listed as discontinued.

FDA approved ANDA077247 for three carboplatin injectable products from Fresenius Kabi USA; all listed strengths are marked discontinued.

The Korean Pharmacists Association continued its 345-day relay rally in front of the Blue House, urging reforms to the han-yak-sa licensing system and resolution of longstanding issues.

FDA records ANDA087397 for Watson Labs' oral tablet BETHANECHOL CHLORIDE 50 mg, currently marked discontinued.

The FDA granted approval (AP) for ANDA 076672, an oral gabapentin solution 250 mg/5 ml submitted by TARO. The product is listed as discontinued.

Ranbaxy received a tentative FDA approval for two oral tablet strengths of Tolterodine tartrate (1 mg and 2 mg) under ANDA 076953.