Drug firm Strides Pharma Science reported, approval from the US health regulator for generic Prednisone tablets used as an anti-inflammatory medication. Strides Pharma has received approval for Prednisone tablets USP in the strength of 1 mg from the United States Food & Drug Administration (USFDA), Strides Pharma Science said in a filing to the BSE.
The product is a generic version of Schering Corporation's Meticorten tablets in the same strength, it added. 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 filing said.
According to IQVIA MAT July 2020 data, the US market for Prednisone tablets USP 1 mg is approximately USD 12 million (about Rs 88 crore), it added. Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti-inflammatory or an immunosuppressant medication.
It is used in treatment of different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders, Strides said. The company has 126 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 89 ANDAs have been approved and 37 are pending approval,it added.
Recently, the company also USFDA approval for Ursodiol tablets USP in the strengths of 250 mg and 500 mg from the United States Food and Drug Administration (USFDA) for treatment of PBC.
PBC is a progressive disease of the liver caused by a buildup of bile within the liver that results in damage to the small bile ducts that drain bile from the liver.
"Strides Pharma Global, Singapore, has received approval for ," the company said in a regulatory filing.
The product is a generic version of Urso 250 tablets, 250 mg, and Urso Forte Tablets, 500 mg, of Allergan Sales, LLC.
Quoting IQVIA moving annual total (MAT) June 2020 data, Strides Pharma Science said the US market for Ursodiol tablets USP, 250 mg and 500 mg, is approximately $35 million.
According to the company , the product will be manufactured at the company''s flagship facility at Bengaluru and will be marketed by Strides Pharma in the US markets.