Regulatorische Updates

The FDA granted approval for Lupin Pharmaceuticals' prescription nasal spray containing 0.5 mg per spray of CYANOCOBALAMIN under ANDA210629.

The Korean Pharmaceutical Management Center has shifted the reporting deadline for specialized drug shipments scheduled between Sep 16‑19 to Sep 20, due to the re‑designated Constitution Day holiday on Sep 17.

FDA has approved ANDA 207417 for methylphenidate hydrochloride oral solution, 5 mg/5 mL and 10 mg/5 mL strengths, manufactured by Ascent Pharmaceuticals.

The FDA has approved ANDA207047 for an oral clindamycin palmitate hydrochloride solution (75 mg/5 ml) marketed by Heritage Pharmaceuticals under sponsor APPCO.

FDA approved ANDA206666 for Pentamidine Isethionate injectable, a prescription drug administered intramuscularly or intravenously.

President Lee Jae‑myung’s remarks on safe, medically supervised use of mifepristone prompted the government to revisit its approval, sending Hyundai Pharmaceutical’s shares to a limit, though experts caution approval is not guaranteed.

국민의힘 백종헌 의원이 재생의료기관의 인체세포 자가처리 범위 합리화를 위한 법률개정안을 14일 대표발의했습니다.

Lawmaker Cho Bo-yoon convened over 100 officials and experts to discuss systematic maintenance of disability convenience facilities in Korea.

The Ministry of Health and Welfare will create a new Regional Essential Public Healthcare Office, add 29 staff positions and expand AI response units, effective Oct 21.

Celltrion renewed its AAA‑level AEO certification for both export and import, remaining the only pharma company in Korea with the top customs compliance rating.

The Korean Pharmaceutical Association met with the Ministry of Health and Welfare on the 13th to confirm implementation of follow‑up measures on the traditional pharmacist issue and to discuss guidelines for warehouse‑type pharmacies.

The association denounced the Fair Trade Commission’s opposition to the Ministry’s draft rules limiting pharmacy names and ads, calling it unfair interference with public health.