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Diễn biến quy định từ FDA, EMA, TGA và các cơ quan toàn cầu
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30 thg 8, 2026•1 phút đọc
FDA Approves Manufacturing Submissions for XYLOCAINE Ointment (NDA 008048)
The FDA record for NDA 008048 shows XYLOCAINE ointment, a discontinued 5% lidocaine topical, received multiple approved manufacturing and labeling submissions from 1984 to 1996.
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30 thg 8, 2026•1 phút đọc
FDA Discontinues Alprazolam Extended‑Release Tablets (ANDA077777)
FDA records show Sandoz's alprazolam extended‑release tablets (product numbers 001‑004) are discontinued, with multiple labeling supplement approvals.
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30 thg 8, 2026•1 phút đọc
FDA Approves Abbott's Calcium Gluceptate Injection (ANDA083159)
FDA approved Abbott's Calcium Gluceptate injection (ANDA083159) in 1972, with a supplemental manufacturing amendment in 1984; the product is now discontinued.
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30 thg 8, 2026•1 phút đọc
FDA Approves Lilly Methyltestosterone Tablet ANDA080256 (Discontinued)
FDA approved Lilly's ANDA080256 for methyltestosterone tablets (10 mg and 25 mg) buccal/sublingual on Dec 22 1971; both products are now discontinued.
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30 thg 8, 2026•1 phút đọc
FDA Discontinues Piperazine Citrate Syrup (ANDA080774)
The FDA has listed the oral syrup product Piperazine Citrate (product 001) from Alpharma US Pharms as discontinued under ANDA080774.
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30 thg 8, 2026•1 phút đọc
South Korea Revamps Innovative Pharma Company Certification to Quantitative Scoring
The Ministry of Health and Welfare has amended regulations to replace qualitative reviews with a scored, quantitative evaluation system for innovative pharmaceutical companies, enhancing predictability and objectivity.
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30 thg 8, 2026•1 phút đọc
Korean AbbVie’s JAK inhibitor Rinbark gains EMA endorsement for alopecia areata and vitiligo
AbbVie’s JAK inhibitor Rinbark (upadacitinib) received positive CHMP recommendations to add severe alopecia areata and non‑segmental vitiligo to its label, expanding its autoimmune portfolio.
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30 thg 8, 2026•1 phút đọc
FDA Lists ANDA083760 for Watson Labs' Pyridoxine Hydrochloride Injection (Discontinued)
The FDA database shows an ANDA (application ANDA083760) submitted by Watson Labs for a pyridoxine hydrochloride injectable (100 mg/mL) that is currently listed as discontinued.
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30 thg 8, 2026•1 phút đọc
FDA Approves ANDA084351 for Brompheniramine Maleate 4 mg Tablet (Now Discontinued)
The FDA granted approval (ANDA084351) for a 4 mg oral tablet of brompheniramine maleate by IVAX Sub Teva Pharm; the product is currently listed as discontinued.
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30 thg 8, 2026•1 phút đọc
FDA Approves ACETAZOLAMIDE Oral Tablet (ANDA084840)
The FDA has approved an ANDA for ACETAZOLAMIDE 250 mg oral tablets, with original and multiple supplemental approvals for labeling and manufacturing from 1978 to 2016.
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30 thg 8, 2026•1 phút đọc
FDA Approves KV PHARM Acetaminophen/Codeine Phosphate Tablet (ANDA085288)
FDA approved KV PHARM's oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate (ANDA085288). Multiple labeling submissions were filed; the product is now discontinued.
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30 thg 8, 2026•1 phút đọc
FDA Approves Multiple Labeling and REMS Updates for Hydrocodone Bitartrate/Ibuprofen Oral Tablet (ANDA 076604)
The FDA has approved a series of labeling and REMS submissions for the prescription oral tablet combining 7.5 mg hydrocodone bitartrate and 200 mg ibuprofen under ANDA 076604.