규제 업데이트

The FDA has listed the oral prednisolone 5 mg tablet (product 001) from sponsor Bundy as discontinued under ANDA083675.

FDA records indicate that Watson Labs' injectable product COBAVITE, containing 1 mg/mL cyanocobalamin, is listed as discontinued under ANDA083064.

The FDA granted approval (ANDA080718) for BEL MAR's thiamine hydrochloride injectable product, listed as discontinued.

The FDA has approved the prescription transdermal patch TRANSDERM SCOP, containing 1 mg scopolamine per 72 hr, under NDA 017874. Baxter Healthcare is the manufacturer.

The Korea Pharmaceutical Safety Management Agency will hold a mandatory training on September 29 for dental, veterinary, pharmacy and wholesale professionals on new narcotics safety reporting and supervision rules.

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 ANDA078384 for carvedilol oral tablets (3.125‑25 mg) manufactured by Unichem Pharmaceuticals and sponsored by Regcon Holdings.

Stryker reports a labeling error in one lot of T2 Alpha IMN advanced locking screws, which contain 75 mm screws instead of the specified 57.5 mm.

The FDA’s NDA007504 approval for ACTHAR injectable (25 UNITS/VIAL and 40 UNITS/VIAL) by Sanofi Aventis includes multiple priority labeling supplements, though the products are listed as discontinued.

FDA approved NDA017780 for PHARM SPEC's Heparin Sodium injectable products, listing five strengths now marked discontinued.

Lawmaker Park Yong-gap introduced a bill to designate national university hospitals as core institutions for regional comprehensive medical systems, aiming for balanced national development.

The US 5th Circuit Court of Appeals upheld a lower‑court ruling, dismissing PhRMA’s challenge to the Medicare drug‑price negotiation provisions of the Inflation Reduction Act, noting participation is voluntary.