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규제 업데이트

FDA, EMA, TGA 및 글로벌 규제 동향

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규제 업데이트
2026년 9월 25일•1분 읽기
FDA Marks PANRAY's THEOLIXIR Oral Elixir as Discontinued (ANDA084559)
The FDA’s ANDA084559 filing shows PANRAY’s oral elixir THEOLIXIR, containing THEOPHYLLINE 80MG/15ML, is listed as discontinued.
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규제 업데이트
2026년 9월 25일•1분 읽기
FDA Approves ANDA 076886 for Fosphenytoin Sodium Injection (DR REDDYS)
The FDA granted approval for ANDA 076886, a fosphenytoin sodium injection by DR REDDYS, now listed as discontinued. Original approval in 2007 with labeling updates in 2020.
UPDATED
규제 업데이트
2026년 9월 23일•1분 읽기
Korean Health & Welfare Committee Tensions Over MFDS Role Amid Minister Nominee Scrutiny
The first regular Health and Welfare Committee meeting showed sharp partisan clashes, focusing on the MFDS’s responsibility linked to the Justice Minister nominee.
UPDATED
규제 업데이트
2026년 9월 20일•1분 읽기
Korean Health Insurance Union Opposes 2027 Premium Rate Freeze
The National Health Insurance Labor Union criticized the government's decision to keep the 2027 health insurance contribution rate unchanged, warning it could accelerate financial deterioration amid rising medical demand.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Discontinues Testosterone Injectable (Product 001) – Submission History
The FDA has marked the testosterone injectable (product 001) as discontinued, with a record of multiple labeling and manufacturing submissions dating back to 1983.
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규제 업데이트
2026년 9월 19일•1분 읽기
FDA Approves Over-the-Counter Famotidine ANDA077367 for Dr. Reddy's Labs
The FDA has granted approval for an over‑the‑counter famotidine tablet (10 mg and 20 mg) under ANDA 077367, sponsored by Dr. Reddy’s Laboratories Ltd.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Discontinues UTICORT Topical Lotion (NDA017528)
The FDA record shows UTICORT lotion, a 0.025% betamethasone benzoate topical product by Parke‑Davis, is listed as discontinued.
UPDATED
규제 업데이트
2026년 9월 19일•1분 읽기
FDA Discontinues Triamcinolone Acetoinide 0.1% Cream (ANDA 088095)
The FDA has listed the topical Triamcinolone Acetoinide 0.1% cream, sponsored by Morton Grove, as discontinued under ANDA 088095.
UPDATED
규제 업데이트
2026년 9월 16일•1분 읽기
FDA Discontinues HALOPERIDOL Injectable (ANDA070802)
The FDA has marked the HALOPERIDOL injectable (product 001) as discontinued under application ANDA070802 submitted by Smith & Nephew.
UPDATED
규제 업데이트
2026년 9월 16일•1분 읽기
FDA ANDA202002: Strides Pharma Submits Original Application for IMIQUIMOD 5% Cream
Strides Pharma filed ANDA202002 for a 5% IMIQUIMOD topical cream (product 001). The original submission was listed as approved on 24‑Jun‑2014.
UPDATED
규제 업데이트
2026년 9월 16일•1분 읽기
FDA Approves ARGATROBAN Injection (ANDA091665)
The FDA has approved ANDA091665 for ARGATROBAN injection, a prescription anticoagulant submitted by PH HEALTH.
UPDATED
규제 업데이트
2026년 9월 16일•1분 읽기
FDA Approves ANDA081095 for Oral Acetaminophen/Aspirin/Codeine Capsule (Discontinued)
The FDA granted approval for labeling and manufacturing submissions for ANDA081095, a discontinued oral capsule combining acetaminophen, aspirin, and codeine phosphate, sponsored by MIKART.