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Diễn biến quy định từ FDA, EMA, TGA và các cơ quan toàn cầu

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31 thg 8, 2026•1 phút đọc
FDA Approves ANDA083389 for Lidocaine Hydrochloride with Epinephrine Injection (Discontinued)
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.
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31 thg 8, 2026•1 phút đọc
FDA Approves Multiple Submissions for CYCLOCORT Topical Cream (NDA018116)
The FDA has approved a series of labeling and manufacturing submissions for the discontinued CYCLOCORT cream, noting no safety concerns.
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31 thg 8, 2026•1 phút đọc
FDA ANDA089606: Watson Labs' PROCHLORPERAZINE EDISYLATE Injection Discontinued
The FDA’s ANDA089606 filing for Watson Labs’ prochlorperazine edisylate injectable is listed as discontinued, detailing route, dosage form, and active ingredient.
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31 thg 8, 2026•1 phút đọc
FDA Discontinues ANDA089249 for NANDROLONE DECANOATE Injection
The FDA has listed the ANDA089249 application for NANDROLONE DECANOATE injectable by Quad Pharms as discontinued, noting its marketing status and product details.
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31 thg 8, 2026•1 phút đọc
FDA Approves ANDA 088872 for Thioridazine Hydrochloride Tablet (Discontinued)
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.
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31 thg 8, 2026•1 phút đọc
FDA Approves Ranbaxy Ramipril Capsules (ANDA078849)
FDA approves ANDA078849 submitted by Ranbaxy Labs Ltd for oral ramipril 5 mg and 10 mg capsules, both listed as discontinued.
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31 thg 8, 2026•1 phút đọc
FDA Issues ANDA078545 Approval for Discontinued Lamivudine Tablet Products
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.
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31 thg 8, 2026•1 phút đọc
Korean Medicine Committee Urges International Decoction Oversight
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.
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31 thg 8, 2026•1 phút đọc
Daewoong Pharmaceutical Starts Phase 3 Trial of Pecusclu for Maintenance Therapy in Erosive Esophagitis
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.
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31 thg 8, 2026•1 phút đọc
Seongdong-gu Pharmaceutical Association Holds 7th Board Meeting, Tackles Pharmacy Solicitation and Integrated Care Plans
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.
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31 thg 8, 2026•1 phút đọc
FDA Approves ANDA078249 for Torsemide Tablets by Aurobindo Pharma
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.
UPDATED
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31 thg 8, 2026•1 phút đọc
FDA Approves Labeling for Lupin’s Meloxicam Tablets (ANDA 077944)
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.