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药物批准
34
批准总数
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1
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FDA
Food and Drug Administration
- Alembic Pharmaceuticals received FDA approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, therapeutically equivalent to the reference drug. - The approved product targets hypoprothrombinemia due to vitamin K deficiency and vitamin K-deficiency bleeding in neonates, entering a $44 million market. - This approval brings Alembic's total ANDA approvals to 225, positioning the company to capitalize on the growing generic sterile injectables market projected to reach $251.03 billion by 2030.