規制動向

The FDA granted approval (NDA017421) for DIAL’s discontinued topical solution containing 0.25% hexachlorophene.

The Ministry of Health and Welfare appointed attorney Lee Chang-hoon as the 5th director of the Korea Medical Dispute Mediation and Arbitration Agency, effective Sep 1, 2026.

The FDA records show OxyMorphone Hydrochloride extended‑release tablets are discontinued, yet several labeling and REMS submissions for the product have been approved.

The FDA has marked the oral CHLORPHENIRAMINE MALEATE 4 mg tablet (product 001) from sponsor PVT FORM as discontinued under ANDA080786.

The FDA approved labeling for SCHERING's ORETON buccal tablet containing 10 mg methyltestosterone (application ANDA080281). The product is listed as discontinued.

The FDA has granted approval for Zenara’s aminocaproic acid injectable (250 mg/mL) under ANDA215374, classified as a prescription product.

The FDA has listed NDA 214937 for a prescription helium inhalation gas (HELIUM, USP) submitted by Westair Gases & Equipment Inc., with submission documents dated June‑July 2020.

The FDA has approved ANDA214528 for Ephedrine Sulfate injection, a 50 mg/mL intravenous solution manufactured by Sagent Pharmaceuticals.

The FDA has approved Teva Pharm USA's ANDA214126 for two intravenous SUGAMMADEX SODIUM solutions (200 mg/2 mL and 500 mg/5 mL).

Laurus Labs Ltd filed a Type 4 New Combination NDA (213696) with the FDA, recorded as a standard priority original submission on Jan 25 2022.

FDA granted approval for PHYTONADIONE tablets, a vitamin K generic from Agnitio Inc., under ANDA213336 on Oct 12, 2023.

The FDA granted additional approval for Eli Lilly’s Mounjaro (tirzepatide) to lower major cardiovascular events in adults with type 2 diabetes and existing cardiovascular risk, matching Novo Nordisk’s Ozempic indication.