규제 업데이트

The FDA has approved Sun Pharmaceutical's epoprostenol injectable (ANDA210473), covering 0.5 mg and 1.5 mg vial strengths for intravenous use.

The FDA has approved CARDIZEM CD, an extended‑release oral capsule of diltiazem hydrochloride (NDA020062), manufactured by Bausch Health US LLC.

The FDA approved Lupin’s injectable DOXERCALCIFEROL (4 mcg/2 ml) under ANDA210801; the product is listed as discontinued.

Pharmacist groups in Korea are demanding emergency meetings and protesting as the government hints at broader drug delivery linked to telemedicine, fearing impacts on professional roles and local pharmacies.

South Korea's MFDS updates its pre‑GMP evaluation handbook after 5 years, introducing dedicated teams for new drugs and incorporating the Korea‑Singapore GMP mutual‑recognition agreement.

The FDA approved STEGLATRO, an oral ertugliflozin tablet (5 mg and 15 mg) from Merck Sharp & Dohme, NDA209803.

The FDA’s database shows several THORAZINE oral, rectal, and injectable products marked as discontinued, with a Federal Register note that discontinuations were not for safety or effectiveness reasons.

Pharmacists' group 약준모 will protest on Sep 13 in front of the Blue House, opposing the government's plan to broaden home delivery of prescription drugs for telemedicine patients.

The FDA approved ANDA209102 for generic baclofen oral tablets in 5‑20 mg strengths, manufactured by TruPharma, Advagen Pharma and SOLA Pharmaceuticals.

The FDA has approved application ANDA208756 submitted by Rhodes Pharm for oral dexmethylphenidate hydrochloride tablets in 2.5 mg, 5 mg and 10 mg strengths, though the products are listed as discontinued.

VARUBI, an intravenous rolapitant hydrochloride emulsion by TERSERA, received FDA approval (NDA 208399) with original submission in 2017 and labeling updates in 2018 and 2020; marketing status is discontinued.

The FDA granted approval for an OTC oral tablet of lansoprazole 15 mg under NDA 208025, listed under several brand names and marketed by multiple retailers.