Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves NIPRIDE (Sodium Nitroprusside) Injection – NDA 017546
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.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA076914 for Tramadol Hydrochloride and Acetaminophen Tablet
The FDA has approved ANDA076914 for a discontinued oral tablet combining 37.5 mg tramadol hydrochloride and 325 mg acetaminophen, submitted by Graviti Pharms.
Regulatory Updates
Sep 11, 2026•1 min read
South Korea Health Ministry appoints Kim Eun‑young as Basic Living Security Department Manager
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.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approval History for CYLERT (NDA 017703)
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.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Risperidone Tablet ANDA077784 Submitted by Ratipharm
FDA approved ANDA077784 for multiple oral risperidone tablet strengths submitted by Ratipharm; all listed products are marked discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA076609 for Propoxyphene Napyslate/Acetaminophen Tablet
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.
Regulatory Updates
Sep 11, 2026•1 min read
MFDS Revises Pharmaceutical Pre‑GMP Evaluation Manual, Adds New‑Drug and Singapore GMP Provisions
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.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Reports Discontinuation of Multiple THORAZINE Products
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.
Regulatory Updates
Sep 10, 2026•1 min read
South Korea proposes amendment to require employers to stock emergency medicines at workplaces
A pharmacy‑law amendment introduced by lawmaker Jeon Yong‑gi would obligate businesses to keep and provide safety standby medicines for employee emergencies.
Regulatory Updates
Sep 10, 2026•1 min read
Stryker T2 Alpha IMN Advanced Locking Screw Lot Mislabelled, 75 mm Instead of 57.5 mm
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.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Grants Approval for Metoprolol Tartrate Injectable (ANDA078085) by Hospira
The FDA has approved Hospira’s Metoprolol Tartrate injectable (ANDA078085), an intravenous prescription drug with a 1 mg/mL strength.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves Amici Pharma’s Generic Pravastatin Sodium Tablets (ANDA 077491)
The FDA has approved the ANDA 077491 for Pravastatin Sodium tablets from Amici Pharma, covering strengths from 10 mg to 80 mg.