Aurobindo, Glenmark get FDA nod for generic asthma drug

New Delhi: Drug firms Aurobindo Pharma and Glenmark today said they have received approval from the US health regulator to manufacture and market generic montelukast sodium tablets used for treating asthma and allergies.

Both the companies said they would immediately commence distribution of the product in the US market.

Quoting IMS health data, they said the annual sales of montelukast sodium tablets 10 mg were nearly USD 3.5 billion and that of chewable tablets is USD 1.1 billion for the twelve months ending March 2012.

In a statement Aurobindo Pharma said: "The company has received final approval from the USFDA to manufacture and market montelukast sodium tablets 10mg and montelukast sodium chewable tablets 4mg and 5mg."

Similarly, Glenmark Pharmaceuticals also said its US arm Glenmark Generics Inc, has been granted final abbreviated new drug approval (ANDA) from the US Food and Drug Administration (USFDA) for montelukast sodium tablets in 10mg strength.

The tablets are generic version of pharma major Merck & Co`s Singulair tablets, indicated for the treatment of asthma, allergic rhinitis and prophylaxis.

Last week, the USFDA had for the first time approved sales of generic version of Singulair by various firms, including Indian companies such as Aurobindo Pharma, Glenmark Generics and Torrent Pharmaceuticals.

Shares of Glenmark Pharmaceuticals, Aurobindo Pharma and Torrent Pharmaceuticals were trading at Rs 417.60, Rs 113.50 and Rs 674.10 in the afternoon trade on BSE, up 2.18 per cent, 0.04 per cent and 0.72 per cent respectively from their previous close.