Aurobindo, Glenmark get USFDA nod for generic asthma drug

[prasad]

Drug makers Aurobindo Pharma and Glenmark have received the US health regulatory approval to manufacture and market generic montelukast sodium tablets used for treating asthma and allergies. The two firms would immediately commence distribution of the product in the US market.

The annual sales of montelukast sodium tablets (10 mg) stood at nearly $3.5 billion and that of chewable tablets at $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."



Glenmark Pharmaceuticals 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 Aurobindo Pharma traded 1 per cent higher at Rs 112.30 on the BSE at 1.25 p.m., while Glenmark shares were up 0.7 per cent at Rs 411.55. In contrast, the BSE healthcare index traded 0.6 per cent higher.

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