Regulatory Updates

FDA, EMA, TGA and global regulatory developments

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Regulatory Updates

Sep 3, 2026•1 min read

FDA Approves Apotex CILOSTAZOL (ANDA077030)

FDA has approved Apotex's oral cilostazol tablets (50 mg and 100 mg) under ANDA 077030, adding a generic phosphodiesterase‑3 inhibitor to the market.