Regulatorische Updates

The FDA has approved Torrent Pharmaceuticals' generic esomeprazole magnesium delayed‑release oral suspension (ANDA212652), a prescription oral drug with 10 mg base per packet.

The Korean Pharmacists Association held its first strategy meeting to plan a September 20 nationwide rally, focusing on protecting public health rights and opposing the expansion of telemedicine and drug delivery services.

MFDS says statistical significance alone isn’t enough for functional food ingredient approval; proper trial design and consistent functional outcomes are required.

The FDA approved application ANDA091667 for oral MISOPROSTOL tablets (0.1 mg and 0.2 mg) from Novel Labs, though both products are listed as discontinued.

Pharma companies in Korea have identified abnormal distribution of their OTC drugs on an online shopping mall that also sells supplements and masks, prompting a response to curb illegal sales.

The FDA has approved Chartwell Rx's ANDA091340 for the ophthalmic solution TRAVOPROST (0.004%) as a prescription product.

The Korean pharmacist community is launching a full‑scale campaign against the government's plan to broaden delivery of prescription drugs for telemedicine, with the Korean Pharmaceutical Association forming an emergency task force.

The FDA approved ANDA083784 for a 12.5 mg oral Meclizine Hydrochloride tablet submitted by IVAX Sub Teva Pharm; the product is currently listed as discontinued.

FDA has approved an ANDA for a 1 mg oral folic acid tablet submitted by PurePac Pharm; the product is listed as discontinued.

FDA listed ANDA083183 for diphenhydramine hydrochloride injection (50 mg/mL) from sponsor Hikma; approved on 12 Oct 1973, marketing status discontinued.

The FDA approved ANDA080279 for a 5 mg oral prednisone tablet submitted by Inwood Labs; the product is listed as discontinued.

The FDA approved ANDA079044 for a nicotine polacrilex chewing gum marketed as an over‑the‑counter product, with multiple manufacturers listed.