Strides Shasun Limited has received the first to file tentative approval from the United States Food & Drug Administration (USFDA) for Roflumilast tablets, 500 mcg. The product received approval in 15 months under the new the Generic Drug User Fee Amendments of 2012 (GDUFA) goal date regime. The product can be launched earliest by January 2020.

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

According to IMS data, the US market for Roflumilast tablets 500 mcg is approximately USD 174 million. Roflumilast tablets registered a healthy growth of 16 per cent in value terms and 5 per cent in volume terms in US (IMS March 2016 MAT data). Based upon available information, company believes it is amongst the first wave of ANDA applicants for Roflumilastwith a Paragraph IV certification, which is under litigation as per the provisions of the Hatch-Waxman Act. On receiving full approval, the product will be manufactured at the company’s Oral dosage facility at Bengaluru and marketed by Strides Shasun in the US Market.

Strides Shasun, has a global manufacturing foot print with 14 manufacturing facilities spread across three continents including 6 US FDA approved facilities and 8 facilities for the emerging markets. The company has three dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 85 countries.