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Pharma cos set to gain from US nod for asthma drug

Pharma major Merck has had patent for Singulair and it has been a blockbuster drug for the company

Press Trust of India  |  New Delhi 



New Delhi, Aug 5 (PTI) Indian drug makers, including Aurobindo and Glenmark, are set to benefit from a decision by the USFDA to allow sale of generic Singulair tablets used for treating asthma and allergies in the US market.


Last week the US Food and Drug Administration (USFDA) announced the approval of the first generic versions of Singulair (montelukast sodium) tablets for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

Pharma major Merck has had patent for Singulair and it has been a blockbuster drug for the company. The drug is reported to have annual sales of $5 billion.

"For people who suffer from chronic health conditions such as asthma and allergies, it is important to have effective and affordable treatment options," FDA's Center for Drug Evaluation, Office of Generic Drugs Director Gregory P Geba said.

The generic products approved would expand those options for patients, he added.

Among the Indian firms which have received approval include Aurobindo Pharma, Glenmark Generics and Torrent Pharmaceuticals.

"Apotex Inc, Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland Inc, Mylan Inc, Roxane Laboratories, Sandoz Inc, Teva Pharmaceuticals Inc, and Torrent Pharmaceuticals have gained FDA approval for generic montelukast tablets," the USFDA said on its website.

While Apotex, Aurobindo, Endo, Kudco, Mylan, Roxane, Sandoz, Teva, and Torrent have received approval for chewable tablets, Teva has received approval for the oral granule form.

The Generic drugs approved by USFDA are of the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those for brand-name drugs, the US health regulator said.

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First Published: Sun, August 05 2012. 13:12 IST
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