Strides Pharma Science today said its step-down wholly owned subsidiary has received acceptance from the US health regulator for two key abbreviated new drug applications (ANDAs).
“Strides Pharma Global Pte. Ltd, Singapore, received ANDA ‘acceptable for filing’ correspondence from the US Food and Drug Administration (USFDA) for two key ANDAs that met the prioritisation factors as a potential first generic,” Strides Pharma Science said in a regulatory filing.
The company said the two products could be eligible for a potential 180-day exclusivity.
Quoting IQVIA MAT data, Strides Pharma Science said the US market for these products cumulatively is USD 550 million.
“The USFDA also granted Strides’ request to designate the drug product under these ANDAs as a competitive generic therapy (CGT),” it added.
Strides Pharma Science said approval of the CGT designated ANDAs will be contingent on certain conditions including continued USFDA approval status for the manufacturing plant, API supplier. PTI SVK ANS ANS