New Delhi: Drug firm Strides Shasun said it has received approval from the US health regulator to market Ketoconazole tablets, used to treat fungal infections, in the American market.
Strides Pharma Global Pte, a wholly-owned subsidiary of the company, has received final approval from the US Food and Drug Administration (USFDA) for the product, Strides Shasun said in a statement.
The Bengaluru-based company’s product is the generic version of Janssen Pharmaceutical’s Nizoral tablets, which is indicated to treat certain serious fungal infections in the body.
As per IQVIA MAT April 2018 data, sales of Ketoconazole Tablets in the US market stood at around USD 7 million.
The company will manufacture the generic product at its oral dosage facility in Bengaluru. It will be marketed in the US market by Strides Pharma Inc.
The company claimed it has 75 cumulative abbreviated new drug applications (ANDA) filings with USFDA, of which 49 have been approved as of the date and 26 are pending approval.