Strides receives USFDA tentative approval for Roflumilast

Strides Shasun announced that it has received tentative approval from the United States Food & Drug Administration (USFDA) for Roflumilast Tablets, 500 mcg


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Roflumilast is used to prevent worsening of symptoms in people with severe chronic obstructive pulmonary disease (COPD).

The product received approval in 15 months under the new GDUFA goal date regime.

The product will be launched earliest by January 2020.

According to IMS data, the US market for Roflumilast Tablets 500 mcg is approximately $174 million.

Roflumilast tablets registered a healthy growth of 16% in value terms and 5% in volume terms in US (IMS March 2016 MAT data).


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