규제 업데이트

The U.S. FDA has approved Priovant Therapeutics' dual TYK2/JAK1 inhibitor brepocitinib, branded Lisraya, as a once‑daily oral treatment for adult dermatomyositis, marking the first targeted therapy for this steroid‑dependent disease.

In recent employment‑policy discussions, health‑care, telemedicine, and platform businesses were highlighted for deregulation, prompting the pharmacy community to seek swift policy solutions.

The FDA granted approval (status AP) for ANDA212957 submitted by Chartwell Rx for the intravenous powder Fosaprepitant Dimeglumine, which is listed as discontinued.

The FDA has approved Aurobindo Pharma’s pirfenidone tablets (ANDA 212596) for prescription use, available in 267 mg and 801 mg strengths.

The FDA has approved the ANDA212257 application for PROCHLORPERAZINE EDISYLATE injectable, manufactured by Somerset Therapeutics, for intramuscular and intravenous use.

Fintepla (fenfluramine HCl) entered insurance coverage on the 1st and was immediately classified as a telemedicine‑prescription‑prohibited drug. Dayvigo film‑coating tablets for insomnia were also added to the prohibited list.

The FDA has approved application ANDA216216 for METOLAZONE oral tablets in 2.5 mg, 5 mg, and 10 mg strengths, sponsored by NE RX Pharma.

The FDA has approved NDA020607 for ARTHROTEC, a prescription oral delayed‑release tablet combining diclofenac sodium with misoprostol in 50 mg/0.2 mg and 75 mg/0.2 mg strengths.

Yuyu Pharmaceutical re‑shipped four voluntarily recalled items, including Tanamin tablets, before official recall closure, prompting the MFDS to impose a 15‑day manufacturing halt. The action was due to procedural lapses, not product safety.

South Korea's Ministry of Health and Welfare unveiled a four‑year, stepwise drug price ceiling re‑evaluation plan that includes extra 20% cuts for non‑compliant drugs and a safeguard against lowering already low prices.

The FDA granted approval for NDA020675 covering URSO 250 (250 mg) and URSO FORTE (500 mg) ursodiol tablets from Allergan, though both products are now listed as discontinued.

The FDA approved ANDA 078408 for Vinorelbine Tartrate injectable product from Ebewe Pharma. The product is listed as discontinued.