規制動向

Teva Pharm USA's ANDA211272 for Mycophenolate Mofetil oral suspension (200 mg/mL) received FDA approval, with several REMS and labeling supplements also approved.

FDA has approved application ANDA210929 for tacrolimus oral capsules submitted by Hangzhou Zhongmei Huadong Pharmaceutical, with three discontinued dosage strengths listed.

The FDA has approved ANDA210596 for VYDUO, an oral tablet combining nebivolol hydrochloride (5 mg) and valsartan (80 mg), submitted by Prinston Inc.

The FDA’s NDA215007 for NexAir’s carbon dioxide inhalation gas (USP) is listed with approval status AP, detailing route, dosage form, and NDC codes.

Korea Disease Control Agency advises nursing homes to secure Paxlovid stocks and use Bebtelovimab based on patient condition amid rising COVID‑19 cases.

Three OTC medicines were found listed for sale on an online shop, even after a recent fine for illegal online dispensing, highlighting gaps in drug safety oversight.

Korean authorities say legality of warehouse‑type pharmacies should be judged by funding sources and external influence, not just size, as corporate operators increasingly enter the market.

Chairwoman Yeo Yoon‑jung warned that expanding pharmacy services to convenience stores and non‑face‑to‑face medication delivery could raise concerns for members, as the rollout may extend beyond current vulnerable groups.

FDA has approved ANDA214215 for Zydus' injectable verapamil hydrochloride (2.5 mg/mL), a prescription IV product for cardiovascular use.

FDA approved ANDA213773 for the subcutaneous injectable prescription drug ICATIBANT, manufactured by Alembic Pharmaceuticals.

STERIS reports that some RAPICIDE™ Part A bottles may bulge due to blocked vent caps, posing a risk of off‑gassing and exposure if PPE is not used.

A small number of RAPICIDE™ Part A bottles may bulge due to blocked vent caps, potentially releasing vapor and exposing users; STERIS will notify affected consignees and provide replacements.