法规动态

The FDA approved ANDA083389 for a lidocaine hydrochloride 1% injection containing 0.01 mg/mL epinephrine, submitted by Dell Labs; the product is listed as discontinued.

The FDA has approved a series of labeling and manufacturing submissions for the discontinued CYCLOCORT cream, noting no safety concerns.

The FDA’s ANDA089606 filing for Watson Labs’ prochlorperazine edisylate injectable is listed as discontinued, detailing route, dosage form, and active ingredient.

The FDA has listed the ANDA089249 application for NANDROLONE DECANOATE injectable by Quad Pharms as discontinued, noting its marketing status and product details.

The FDA has approved ANDA 088872 for an oral tablet of thioridazine hydrochloride (200 mg) submitted by Watson Labs Teva, though the product is listed as discontinued.

FDA approves ANDA078849 submitted by Ranbaxy Labs Ltd for oral ramipril 5 mg and 10 mg capsules, both listed as discontinued.

The FDA’s ANDA078545 submission by Pharmobedient lists two oral lamivudine tablets (150 mg and 300 mg) that are marked as discontinued, with an approval status dated March 5 2019.

The Korean Medical Association’s Korean Medicine Countermeasure Special Committee demands international‑standard oversight of external decoction rooms after a police‑investigated insurance fraud involving pre‑manufactured herbal prescriptions.

Daewoong Pharma has received MFDS approval to begin a domestic Phase 3 study of its new drug Pecusclu (20 mg) aimed at securing a maintenance indication after treatment of erosive esophagitis.

The Seongdong-gu Pharmaceutical Association held its 7th regular board meeting, discussing new pharmacy solicitation practices and committing to visit violators, while pledging participation in the 2026 integrated care multi‑drug management project for seniors and disabled.

The FDA has approved application ANDA078249 for torsemide oral tablets, manufactured by Aurobindo Pharma and Rising Pharma Holdings, covering strengths from 5 mg to 100 mg.

The FDA’s database lists ANDA 077944 for meloxicam tablets (7.5 mg and 15 mg) by Lupin Pharmaceuticals, with several labeling submissions approved; the products are currently marked discontinued.