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Jubilant Gets US Regulator Nod for Two Drugs

The company has received final approvals from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mycophenolate Mofetil capsules and tablets, manufactured by the company's US arm Jubilant Cadista Pharmaceuticals Inc, and Rizatriptan tablets made at Jubilant Generics Ltd, Jubilant Life Sciences said in a filing to the BSE.
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Jubilant Gets US Regulator Nod for Two Drugs

New Delhi: Drug firm Jubilant Life Sciences has received final approvals from the US health regulator for its generics Mycophenolate Mofetil, an immuno-suppressant, and Rizatriptan, used for treatment of migraine, in the American market.

The company has received final approvals from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mycophenolate Mofetil capsules and tablets, manufactured by the company's US arm Jubilant Cadista Pharmaceuticals Inc, and Rizatriptan tablets made at Jubilant Generics Ltd, Jubilant Life Sciences said in a filing to the BSE.

The approvals are for Mycophenolate Mofetil in the strengths of 250 mg capsules and 500 mg tablets and Rizatriptan tablets in strengths of 5 mg and 10 mg, it added.



The company's Mycophenolate Mofetil is a generic version of Roche's Cellcept while Rizatriptan tablets are generics of Merck's Maxalt tablets.

"The current annualised US market size for Mycophenolate Mofetil USP, 250 mg capsules and 500 mg tablets, is $245 million and for Rizatriptan Tablets 5 mg and 10 mg it is $70 million, as per IMS" Jubilant Life Sciences said.

As on September 30, 2014, the company had a total of 781 filings for formulations, of which 322 have been approved in various regions globally. This includes 72 ANDAs filed in the US and 46 dossier filings in Europe, it added.

Shares in Jubilant Life Sciences closed 0.21 per cent lower at Rs 139.70 apiece on Monday.



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