The US Food and Drug Administration (FDA) has granted approval for Teva Pharmaceuticals' Abbreviated New Drug Application to market its generic version of Ortho-McNeil's anticonvulsant Topamax Tablets.
It will be able to market the tablets in 25 mg, 50 mg, 100 mg and 200 mg capacities and shipment of the product has already commenced.
Last year, in the 12 months leading up to December 30th, annual sales of Topamax were around $2.4 billion (£1.68 billion) in the US, based on IMS sales data.
Teva recently announced that the FDA had declined to review a Citizen Petition (CP) regarding COPAXONE, otherwise known as glatiramer acetate injection.
According to Teva, the FDA declined without passing comment on the approvability of an Abbreviated New Drug Application or New Drug Application for a glatiramer acetate injection drug product as "it would be premature and inappropriate to do so at this time".
The FDA has taken no action on the requests Teva presented in its CP
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