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The US health regulator has given its tentative approval to Strides Shasun for Roflumilast tablets that are used in the treatment of inflammatory conditions of the lungs.
Strides Shasun has said in a BSE filing that the company has got tentative approval from the US Food and Drug Administration (USFDA) for Roflumilast tablets 500 mcg.
It further said that the product has received approval in 15 months under the USFDA’s new product clearance regime of GDUFA. By January 2020, the product can be launched.
