Brief: Recordati Says Generic Abbreviated New Drug Filer Asks US FDA Approval To Market Generic Version Of Own Drug Isturisa
20/10/2026 18:04
BRIEF-Recordati Says Generic Abbreviated New Drug Filer Asks US FDA Approval To Market Generic Version Of Own Drug Isturisa Oct 20 (Reuters) - Recordati Industria Chimica e Farmaceutica S.p.A. RECI.MI:
RECEIVES PARAGRAPH IV NOTICE LETTER FOR ISTURISA
CONFIRMS GENERIC ISTURISA ENTRY NOT EXPECTED BEFORE 2033
ISTURISA PROTECTED BY FIVE FDA ORANGE BOOK PATENTS EXPIRING 2031, 2033, 2035
ABBREVIATED NEW DRUG FILER ASKS U.S. FDA APPROVAL TO MARKET A GENERIC VERSION OF ISTURISA
Further company coverage: RECI.MI
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