The Indian drug company, Jubilant Life Sciences, has announced in a statement that it has received final approvals for its generics Mycophenolate Mofetil, an immuno-suppressant, and Rizatriptan, used for treatment of migraine, from the Food and Drug Administration (FDA) of the U.S., in the American market.
The drug firm has received final approvals for its Abbreviated New Drug Application (ANDA) for Mycophenolate Mofetil capsules and tablets, manufactured by the company's U.S. subsidiary branch, Jubilant Cadista Pharmaceuticals Inc., and Rizatriptan tablets made at Jubilant Generics Ltd, Jubilant Life Sciences said in a filing to the Bombay Stock Exchange.
AdvertisementThe approvals are provided for Mycophenolate Mofetil in the strengths of 250 mg capsules and 500 mg tablets. For Rizatriptan tablets, the strengths of 5 mg and 10 mg were given approval. Mycophenolate Mofetil is a generic version of Roche's Cellcept while Rizatriptan tablets are generics of Merck's Maxalt tablets.
In a statement released by the Jubilant Life Sciences, it was said that, "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."
The company had a total of 781 filings for formulations as of September 30, 2014, of which 322 have been approved in various regions globally. This includes 72 ANDAs filed in the US and 46 dossier filings in Europe, the company said.