Regulatorische Updates
Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Approves Sun Pharma Epoprostenol Injection (ANDA210473)
The FDA has approved Sun Pharmaceutical's epoprostenol injectable (ANDA210473), covering 0.5 mg and 1.5 mg vial strengths for intravenous use.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Approves CARDIZEM CD (Diltiazem Hydrochloride) Extended‑Release Capsules
The FDA has approved CARDIZEM CD, an extended‑release oral capsule of diltiazem hydrochloride (NDA020062), manufactured by Bausch Health US LLC.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Approves Lupin’s DOXERCALCIFEROL Injection (ANDA210801)
The FDA approved Lupin’s injectable DOXERCALCIFEROL (4 mcg/2 ml) under ANDA210801; the product is listed as discontinued.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
Pharmacists Protest Government Push for Expanded Drug Delivery via Telemedicine
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.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
MFDS Revises Pharmaceutical Pre‑GMP Evaluation Manual, Adds New‑Drug and Singapore GMP Provisions
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.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Approves STEGLATRO (ertugliflozin) under NDA209803
The FDA approved STEGLATRO, an oral ertugliflozin tablet (5 mg and 15 mg) from Merck Sharp & Dohme, NDA209803.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Reports Discontinuation of Multiple THORAZINE Products
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.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
South Korean Pharmacists Plan Rally Against Expanded Telemedicine Prescription Delivery
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.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA209102 for Generic Baclofen Tablets
The FDA approved ANDA209102 for generic baclofen oral tablets in 5‑20 mg strengths, manufactured by TruPharma, Advagen Pharma and SOLA Pharmaceuticals.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA208756 for Dexmethylphenidate Tablets (Rhodes Pharm)
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.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Approves VARUBI (rolapitant) Intravenous Emulsion under NDA 208399
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.
Regulatorische Updates
11. Sept. 2026•1 Min. Lesezeit
FDA Approves Over-the-Counter Lansoprazole Tablet (NDA 208025)
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.