法规动态

The FDA approved ANDA 079021 for atomoxetine hydrochloride capsules from Strides Pharma Science, covering strengths from 10 mg to 100 mg.

South Korea’s Food and Drug Safety Administration held a ceremony on Sep 7 to celebrate ‘Cosmetics Day’, highlighting K‑beauty achievements and promoting safety and global competitiveness.

The Global Cosmetics Regulatory Agency Council (GCORAS) was officially inaugurated in Seoul, led by South Korea’s Ministry of Food and Drug Safety, with meetings running through Sept 9.

The FDA has approved ANDA 078713 for Hikma’s injectable Indomethacin Sodium, though the product is listed as discontinued.

The FDA granted approval (status AP) for Vintage Pharms' ANDA078416 covering an oral solution of prednisolone sodium phosphate on Oct 31 2007; the product is listed as discontinued.

GE Healthcare reports an exposed sharp edge inside SIGNA™ Artist and Artist Evo electronics cabinets that may damage power cables and cause an electrical fault or arc flash risk.

GE Healthcare reports an exposed sharp edge inside SIGNA™ Artist and Artist Evo electronics cabinets that could damage power cables and cause an arc flash injury.

Lupin Ltd filed an original ANDA (application number ANDA216716) with the FDA, currently listed as Tentative Approval as of August 13, 2024.

The FDA has approved the ANDA216294 application for a calcitonin salmon injectable (200 IU/mL) manufactured by Amneal Pharmaceuticals.

The FDA has approved ANDA215856 for a 10 mg/mL furosemide injectable, manufactured by Devatis Inc. and sponsored by Saba Ilac Sanayive.

The FDA has approved AUVELITY, an oral extended‑release tablet combining bupropion hydrochloride and dextromethorphan hydrobromide under NDA 215430.

HK Innoen’s GERD medication K‑Cap 50 mg became the first oral solid dosage drug globally to receive an Environmental Product Declaration, highlighting its sustainability credentials.