規制動向

The FDA has granted several labeling approvals for Chartwell Rx’s desloratadine 5 mg oral tablet (ANDA078364), though the product is listed as discontinued.

FDA granted approval for CALCITRIOL injectable products (ANDA078066) from LONG GROVE PHARMS, including a prescription 0.001 mg/mL product and a discontinued 0.002 mg/mL version.

The FDA granted approval for Chartwell Rx's ANDA077766, covering five discontinued Simvastatin tablet strengths and subsequent labeling updates.

Teva Pharmaceuticals’ oral ramipril capsule products (1.25‑10 mg) were listed as discontinued, with multiple FDA labeling supplements approved between 2008 and 2014.

FDA approved ANDA076589 submitted by Dr Reddys, covering two injectable FLUMAZENIL products, both listed with discontinued marketing status.

The FDA approved ANDA077165 for a preservative‑free granisetron hydrochloride injectable product by Dr. Reddys; the product is listed as discontinued.

Samjin’s third‑generation epilepsy drug Brivaracetam and Jongkundang’s ezetimibe combo LypiroUjet will have reduced insurance prices from next month, with cuts ranging 3‑11%.

The Korean Pharmaceutical Association establishes an emergency response committee to address the government’s plan to broaden delivery of prescription drugs for telemedicine patients.

The Japan PMDA invites comments on draft standards, noting email address formatting and confidentiality rules.

The PMDA outlines how to submit comments on draft regulatory science standards, noting email formatting, public disclosure of submissions, and no individual replies.

The FDA has approved Sandoz's ANDA076873 for a prescription oral metformin hydrochloride 500 mg extended‑release tablet, with multiple labeling supplements approved.

The FDA approved ANDA083022 for the DODEX injectable containing 1 mg/mL cyanocobalamin. The product is listed as discontinued.