Aurobindo gets USFDA nod for asthma drug

Aurobindo Pharma today said it has received the final approval from USFDA to manufacture and market montelukast sodium tablets used for treating asthma and allergies.

The company has received approval to manufacture and market montelukast sodium tablets (10 mg) and montelukast sodium chewable tablets (4 mg and 5 mg) in the US market, it said in a statement.

According to IMS data, the annual sales of Montelukast Sodium Tablets 10mg is approximately USD 3.5 billion and that of Montelukast Sodium Chewable Tablets is USD 1.1 billion for the twelve months ended March 2012, the statement added.

Montelukast Sodium Tablets 10mg and Chewable Tablets 4mg and 5mg are the generic equivalent of Merck & Co Inc's Singulair Tablets 10 mg and Chewable Tablets 4mg and 5mg respectively, the release said.

Last week, the US Food and Drug Administration (USFDA) had announced the approval of the first generic versions of Singulair (montelukast sodium) tablets for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

The approval was granted to several companies, including Apotex, Aurobindo, Endo, Kudco, Mylan, Roxane, Sandoz, and Torrent, which received go ahead for chewable tablets, while Teva has received approval for the oral granule form.

Montelukast sodium is indicated for Prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older and prevention of exercise-induced broncho-constriction in patients 15 years of age and older.

"The products have been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India Aurobindo now has a total of 157 ANDA approvals (131 Final approvals including 1 from Aurolife Pharma LLC and 26 Tentative approvals) from USFDA," the statement added