Natco Pharma submits application with USFDA for Risdiplam for Oral Solution
Hyderabad: Natco Pharma, an Indian pharmaceutical company has announced the submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (USFDA) for the generic version of EVRYSDI (Risdiplam) 0.75 mg/mL For Oral Solution. EVRYSDI is the brand of Genentech Inc.
Risdiplam for Oral Solution is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
"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," the Company stated in a BSE filing.
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*.
NATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven, leading Oncology player in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company’s manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.
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