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Strides Pharma Science receives USFDA approval for Prednisone tablets

The approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Deltasone tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co.

February 12, 2021 / 11:28 AM IST
 
 
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Drug firm Strides Pharma Science on Friday said its subsidiary, Strides Pharma Global Pte Ltd, has received approval from the US health regulator for Prednisone tablets, prescribed for a variety of conditions, including allergies, respiratory illness and arthritis.

Strides Pharma Global Pte Limited, Singapore, has received approval for Prednisone tablets USP in the strengths of 10 mg and 20 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.

The approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Deltasone tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co.

Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti-inflammatory or an immuno-suppressant medication.

It is used in treatment of different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

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Quoting IQVIA MAT December 2020 data, Strides Pharma Science said the US market for Prednisone tablets USP, 10 mg and 20 mg is approximately $60 million.

The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.

The company has 127 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 98 ANDAs have been approved and 29 are pending for approval.

Shares of Strides Pharma Science were trading 2.81 percent higher at Rs 890.10 apiece on BSE.
PTI
first published: Feb 12, 2021 11:27 am

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