Aurobindo gets US FDA nod for anti-asthma, chewable tablets

Chennai: Aurobindo Pharma today announced that it has received the final approvals from the US Food and Drug Administration to manufacture and market ‘montelukast sodium tablets’ and montelukast sodium chewable tablets in the US market.

Montelukast Sodium is used for treating prophylaxis and chronic treatment of asthma, prevention of exercise-induced broncho-constriction in patients older than 15 years of age.

The annual sales of Montelukast Sodium tablets were about $3.5 billion and that of the chewable tablets is $1.1 billion, in the twelve months ending March 2012, says a press release from Aurobindo.

The products are made in Hyderabad.

Aurobindo now has a total of 157 bulk drug approvals from the US FDA, the release said.

In 2011-12, Aurobindo achieved a turnover of Rs 4,281 crore and made a net loss of Rs 42 crore. On the BSE today, the Aurobindo share is trading at around Rs 114.