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USFDA gives nod to Ajanta Pharma for Asthma treatment

USFDA gives nod to Ajanta Pharma for Asthma treatment

Drug firm Ajanta Pharma will now market the generic montelukast tablets and oral granules used for prevention and treatment of asthma and to relieve symptoms of seasonal hay fever

Drug firm Ajanta Pharma has received the green signal from US Food and Drug Administration for its three abbreviated new drug applications (ANDAs). The final approval comes for the montelukast tablets, montelukast sodium chewable tablets and montelukast granules, used for used for prevention and treatment of asthma and to relieve symptoms of seasonal hay fever.

The approval for montelukast tablets in the strength of 10 mg, montelukast sodium chewable tablets have received nod for strengths of 4mg and 5 mg, respectively.

“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.

 

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