規制動向

The FDA has approved ANDA080712 for a thiamine hydrochloride injectable product by BEL MAR; the product is listed as discontinued.

Labsi’s 25 mg twice‑daily oral BTK inhibitor received Korean approval as the first oral therapy for chronic spontaneous urticaria, expanding options beyond injectable second‑line treatments.

A domestically developed human skin model combined with MFDS technology is now part of OECD TG 498, signaling international standardization of Korea’s animal‑free testing methods.

From July 1, South Korea will recognize severe pancreatic dysfunction as a new disability category, benefiting type 1 diabetes patients. A ceremony will mark the first Pancreas Disability Day.

Watson Labs' injectable dexamethasone sodium phosphate (product 001) is listed as discontinued per FDA ANDA083702 filing.

FDA granted approval for ANDA083089 covering two oral capsule strengths of propoxyphene hydrochloride by Roxane; both products are listed as discontinued.

Health Canada reports elevated KPC false‑positive rates in BIOFIRE FilmArray Pneumonia and Joint Infection panels due to contamination in the outer primer pellet.

Starting April 5 2026, Health Canada observed elevated KPC unexpected‑positive rates in final QC testing of BIOFIRE® FILMARRAY® Pneumonia, Pneumonia Plus and Joint Infection panels, linked to nucleic‑acid contamination in the pouch.

The FDA has approved Lumvoa, Viridian Therapeutics’ treatment for thyroid eye disease, creating competition for Amgen’s Tepezza, the sole existing therapy.

Fierce Pharma’s 2026 regulatory tracker logs progress of in‑market products, noting geographic expansions and new indications, even when not full stories.

FDA records show multiple labeling and manufacturing submissions for LOESTRIN 21 1.5/30, a discontinued oral contraceptive tablet, with the latest activity in May 2022.

The FDA has approved labeling for generic levetiracetam tablets, 250 mg to 1 g, from BluePoint Laboratories and Aurobindo Pharma.