法规动态

The FDA has approved INDIUM DTPA IN 111 (NDA 017707), a radiopharmaceutical for intrathecal diagnostic imaging, manufactured by Medi‑Physics/GE Healthcare.

Addpharma, a Yuhan subsidiary, has received approval for a Phase 1 follow‑up trial of its AD-118 reformulation, targeting the post‑patent market for Entresto.

Jeonbuk pharmacists gathered outside the presidential office, urging the government and parliament to resolve the issue of traditional‑medicine pharmacists selling OTC drugs.

월말·월초 청구 집중 시 약국들의 시스템 접속 지연이 반복돼 대한약사회가 건강보험심사평가원에 운영 환경 개선을 요구했다.

FDA approved application ANDA078102 submitted by TARO for meloxicam tablets (7.5 mg and 15 mg). Both products are listed with discontinued marketing status.

The FDA granted a Tentative Approval for Dr Reddys Labs' ANDA 077798, covering oral tablets of Escitalopram Oxalate in 5 mg, 10 mg, and 20 mg strengths.

The FDA has approved a series of supplemental submissions for the oral tablet Amitriptyline Hydrochloride (product 002), originally approved in 1977, now listed as discontinued.

The FDA has approved Teva Pharmaceuticals' generic chlordiazepoxide hydrochloride oral capsules (ANDA 084769) with 25 mg strength and multiple NDC codes.

The FDA has approved application ANDA086148 submitted by Roxane for a 150 mg oral tablet of amitriptyline hydrochloride, now listed as discontinued.

The FDA granted approval for Bausch & Lomb's OFLOXACIN 0.3% ophthalmic solution (prescription) under ANDA 076622, originally approved in May 2004 with a labeling update in 2020.

The Korean Pharmacists Association plans a launch ceremony on the 9th and a large rally on the 13th in front of the Blue House, opposing the government's plan to expand delivery of prescription drugs for telemedicine.

Qurocell’s CAR‑T product Rimkato (anvalkaptagen autologous cell) has cleared the Cancer Disease Review Committee and the Drug Reimbursement Evaluation Committee, opening the path to health‑insurance coverage and a potential market launch within the year.