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    FDA approvals drop 8% in 2025, with fewer blockbusters; Brinsupri, Rhapsido make it to first-in-class list

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    Ketoleucine

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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
    27/02/2026 SIGMA TAU
    U.S.A
    		 SIGMA F AND D DIV LTD 7771 A-KETOISOCAPROIC ACID, SODIUM SALT 1988-11-08 Inactive II N/A
    27/02/2026 Synthelabo Tanabe Chimie
    France
    		 SYNTHELABO PHARMACIE 5920 KETOLEUCINE L-LYSINE SALT 1985-07-05 Inactive II N/A
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