Natco Pharma today announced submission of Abbreviated New Drug Application (ANDA) with USFDA for Risdiplam for Oral Solution.
NATCO believes it is amongst one of the first two companies to have filed a substantially-complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of shared marketing exclusivity at the time of potential launch of the generic product under certain circumstances. NATCO has been named as one of the defendants in a lawsuit filed in the United States District Court for the District of New Jersey by Genentech, Inc., Hoffmann-La Roche Inc., and PTC Therapeutics, Inc.
EVRYSDI has recorded sales of USD 571 million in the US market for the year 2023.
Risdiplam for Oral Solution is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
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