Bangalore-based drug firm Jubilant Biosys Ltd on 5 January 2014 received final approval of the US Food & Drug Administration (FDA) for its generic drugs Mycophenolate Mofetil and Rizatriptan. With this, Indian pharma major will now be able to sell these generic drugs in the American market.
Mycophenolate Mofetil, an immuno-suppressant, is a generic version of Roche's Cellcept whereas tablets of Rizatriptan, used for treatment of migraine, are generics of Merck's Maxalt tablets.
The strengths for which the approvals were given by the USFDA include
• Mycophenolate Mofetil – in strengths of 250 mg capsules and 500 mg tablets
• Rizatriptan tablets - in strengths of 5 mg and 10 mg
Mycophenolate Mofetil capsules and tablets are manufactured by the company's US arm Jubilant Cadista Pharmaceuticals Inc and Rizatriptan tablets are made at Jubilant Generics Ltd, Jubilant Life Sciences.
Where: in US market
When: 5 January 2014