Drug Approval | September 11, 2023
Strides receives USFDA approval for Sevelamer Carbonate for oral suspension
The products will be manufactured at the company's facility in Bengaluru
The products will be manufactured at the company's facility in Bengaluru
The approval bolsters the company's Mycophenolate Mofetil portfolio
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)
The product will be manufactured at Lupin’s facility in Goa, India
The product patent has been already filed under fast track approval
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