Regulatorische Updates

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

FDA has approved ANDA207613, authorizing oral Midodrine Hydrochloride prescription tablets in 2.5 mg, 5 mg, and 10 mg strengths from Umasuto and Rising Pharma.

The FDA has granted approval for LEUCOVORIN CALCIUM (application ANDA207241) manufactured by Fresenius Kabi USA for prescription use.

Teva Canada is recalling a lot of Novo‑Gesic Forte 500 mg acetaminophen tablets due to possible phenolic resin or epoxy contamination that could injure the digestive system.

The FDA has approved the generic drug Sevelamer Hydrochloride (ANDA 206883) from Macleods Pharmaceuticals, available as 400 mg and 800 mg oral tablets.

The FDA has approved application ANDA090935 for oral prescription Warfarin Sodium tablets ranging from 1 mg to 10 mg, manufactured by Exelan Pharmaceuticals.

GE Healthcare reports two potential safety issues affecting order summary components in certain Centricity High Acuity anesthesia systems.

GE Healthcare reports two potential safety issues affecting order and recording summary components in certain Centricity High Acuity systems.

Lawmaker Seo Mi-hwa will hold a policy forum on Sep 4 to discuss new directions for valuing innovative medicines amid emerging therapies.

FDA has granted approval for ANDA090609, allowing Dr. Reddy's Laboratories to market generic atomoxetine hydrochloride oral capsules in multiple strengths.

Beckman Coulter reports a software issue on DxC 500i and DxC 500 AU analyzers where unit settings can revert to defaults without warning.

Beckman Coulter reports a software flaw in DxC 500i and DxC 500 AU clinical chemistry analyzers that can revert user-selected units to defaults when plasma samples are tested, without warning.