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    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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    Pipeline Prospector 2025 highlights: FDA approves pill version of Novo’s Wegovy; BioMarin acquires Amicus for US$ 4.8 bn

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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    29/01/2026 Moehs Iberica
    Spain
    		 MOEHS IBERICA SL 37797 RIMEGEPANT SULFATE 2022-12-23 Active II Complete 2023-11-14 2023-09-26
    29/01/2026 Metrochem API Private Limited
    India
    		 METROCHEM API PRIVATE LTD 43413 RIMEGEPANT SULFATE 2025-12-29 Active II N/A
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