The approval for Prednisone tablets by the US Food & Drug Administration (USFDA) granted to the company's step-down wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, is for multiple strengths of 2.5 mg and 5 mg, Strides Pharma Science said in a regulatory filing.
Strides Pharma Science Ltd on Monday said it has received approval from the US health regulator for its generic version of Prednisone tablets, prescribed for a variety of conditions, including allergies, respiratory illness and arthritis.
The approval for Prednisone tablets by the US Food & Drug Administration (USFDA) granted to the company's step-down wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, is for multiple strengths of 2.5 mg and 5 mg, Strides Pharma Science said in a regulatory filing.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Deltasone tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co, it added.
Citing IQVIA MAT September 2020 data, the company said the US market for Prednisone Tablets USP, 2.5 mg and 5 mg is approximately USD 30 million.
"The product will be manufactured at the company's flagship facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market," it added.
The company has a total of 127 ANDA (abbreviated new drug applications) filings with USFDA of which 93 have been approved and 34 are pending approval.