Ajanta Pharma gets USFDA nod for generic asthma treatment drug

NEW DELHI: Drug firm Ajanta Pharma has received final approvals from the US health regulator for generic montelukast tablets and oral granules used for prevention and treatment of asthma and to relieve symptoms of seasonal hay fever.

The company has "received final approval for its three abbreviated new drug applications (ANDAs) by the United States Food and Drug Administration (USFDA) for montelukast tablets, montelukast sodium chewable tablets and montelukast granules," Ajanta Pharma said.

While the approval is for montelukast tablets in the strength of 10 mg, montelukast sodium chewable tablets have received nod for strengths of 4mg and 5 mg, it added.

"For 12 months ending June 2015, montelukast tablets, chewable tablets and granules had sales of approximately USD 237 million, USD 87 million and USD 31 million respectively, according to IMS health," Ajanta Pharma said.

The company plans to launch the generic products shortly, it added.

Shares of Ajanta Pharma were trading at Rs 1,628 per scrip in the afternoon trade on BSE, up 4.93 per cent from its previous close.