NEW DELHI: Strides Shasun has received tentative approval from the US health regulator for Roflumilast tablets, used for the treatment of inflammatory conditions of the lungs.
The company has received tentative approval from the US Food and Drug Administration (USFDA) for Roflumilast tablets 500 mcg, Strides Shasun said in a BSE filing.
The product has received approval in 15 months under the USFDA’s new product clearance regime of GDUFA. The product can be launched earliest by January 2020, it added.
According to IMS sales data, the US market for Roflumilast tablets 500 mcg is around $ 174 million.
The company will manufacture the product at its oral dosage facility in Bengaluru.