Regulatorische Updates

FDA approved Roche's injectable NIPRIDE (sodium nitroprusside 50 mg/vial) under NDA 017546 in 1974; the product is now discontinued after multiple labeling updates.

The FDA has approved ANDA076914 for a discontinued oral tablet combining 37.5 mg tramadol hydrochloride and 325 mg acetaminophen, submitted by Graviti Pharms.

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.

CYLERT, an oral chewable tablet with 37.5 mg PEMOLINE, is listed as discontinued. The FDA record shows a series of labeling, manufacturing and priority submissions from 1976 to 2005.

FDA approved ANDA077784 for multiple oral risperidone tablet strengths submitted by Ratipharm; all listed products are marked discontinued.

The FDA approved ANDA076609 for a 100 mg propoxyphene napyslate and 650 mg acetaminophen oral tablet submitted by Watson Labs Florida; the product is listed as discontinued.

South Korea's MFDS updates its pre‑GMP evaluation handbook after 5 years, introducing dedicated teams for new drugs and incorporating the Korea‑Singapore GMP mutual‑recognition agreement.

The FDA’s database shows several THORAZINE oral, rectal, and injectable products marked as discontinued, with a Federal Register note that discontinuations were not for safety or effectiveness reasons.

A pharmacy‑law amendment introduced by lawmaker Jeon Yong‑gi would obligate businesses to keep and provide safety standby medicines for employee emergencies.

Health Canada alerts that a Stryker T2 Alpha IMN advanced locking screw lot is mislabeled, containing 75 mm screws rather than the specified 57.5 mm.

The FDA has approved Hospira’s Metoprolol Tartrate injectable (ANDA078085), an intravenous prescription drug with a 1 mg/mL strength.

The FDA has approved the ANDA 077491 for Pravastatin Sodium tablets from Amici Pharma, covering strengths from 10 mg to 80 mg.