規制動向

The FDA has approved ANDA 077139 for Teva Pharm USA’s carboplatin injectable products, with multiple supplemental approvals covering labeling and manufacturing.

FDA granted approval (ANDA076850) for Fougera Pharms' terconazole 80 mg vaginal suppository, now listed as discontinued.

The FDA approved ANDA076296 for a Vincristine Sulfate injectable (1 mg/mL) submitted by Fresenius Kabi USA. The product is listed as discontinued.

FDA records show Isopto Cetamide ophthalmic solution (15% sulfacetamide sodium) received several approved manufacturing and labeling submissions from 1971 to 2000; the product is now discontinued.

The FDA has granted tentative approval for six oral capsule strengths of atomoxetine hydrochloride under ANDA078940, sponsored by Actavis Elizabeth.

FDA has approved an ANDA for buprenorphine sublingual tablets (2 mg and 8 mg) from Hikma Pharmaceuticals USA Inc., with associated labeling and REMS submissions.

Following earlier network‑pharmacy and name‑restriction laws, a new bill targeting external capital in pharmacies entered discussion, aiming to limit operators to one outlet and ban terms like “warehouse.”

Lee Yoon-hak, appointed head of drug price negotiations at Korea’s Health Insurance Review & Assessment Service, vows to boost essential medicine access, foster new‑drug development and ensure rational post‑pricing management.

The EMA Committee on Medicinal Products for Human Use (CHMP) recommended 12 new medicines for approval and issued several biosimilar, generic, re‑examination and indication‑extension updates.

Hanmi Pharm received approval for its 20% azelaic acid cream, AzelClean, as four new azelaic acid products enter a market that has more than tripled in size this year.

Pharmacy students have created a task‑force team to respond to the government’s plan to expand telemedicine drug delivery, holding briefings across universities.

대한약사회는 지난 30년간 약사 직능 관련 주요 현안에 비상대책위원회를 꾸려 의약분업부터 원격 처방 약 배송까지 대응해 왔으며, 그 성과와 한계를 되짚는다.