FDA approves first generic copies of Merck & Co's Singulair; and Pulmicort Respules

6 August 2012

The US Food and Drug Administration on Friday approved the first generic versions of Singulair (montelukast sodium), US drug giant Merck & Co’s drug for the control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

Singulair, which Merck’s best-selling product - generating second-quarter 2012 sales of $1.4 billion for the company, is scheduled to lose patent protection in the USA this month and in Europe in February 2013.

Copy drugmakers Apotex, Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland, Mylan, Roxane Laboratories, Sandoz (the generics unit of Novartis), Teva Pharmaceuticals and Torrent Pharmaceuticals have gained FDA approval for generic montelukast tablets. Apotex, Aurobindo, Endo, Kudco, Mylan, Roxane, Sandoz, Teva and Torrent gained clearance chewable tablets, while Teva has also received approval for an oral granule form.

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