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.

Ranbaxy gets US FDA nod for acne treatment drug

New Delhi: Ranbaxy Laboratories Ltd on Monday got approval from the US Food and Drug Administration to launch Absorica in the US market.

Through a business agreement with the Canadian firm, Cipher Pharmaceuticals Inc, Ranbaxy Laboratories Inc (RLI), a wholly owned subsidiary of RLL is expected to launch Absorica in the US in fourth quarter.

As per the agreement, Ranbaxy will pay royalties on net sales to Cipher. Absorica, a novel, is patented brand formulation of the acne medication isotretinoin, developed by Cipher, for treatment of severe recalcitrant nodular acne.

“Absorica is a milestone in our commitment to serve the dermatology community and will be the flagship brand for Ranbaxy’s specialised dermatology sales force,” Mr Venkat Krishnan, Senior Vice President and Regional Director, Americas, Ranbaxy said in a company statement.