Jubilant receives FDA approval for antipsychotic drug

The current total market size for this product $59 mn per annum

Jubilant Life Sciences Ltd today said it has received approval from the US health regulator to market generic version AstraZeneca's Seroquel used for the treatment of schizophrenia and acute manic episodes associated with bipolar disorder.

The abbreviated new drug applications (ANDAs) approval from the US Food and Drug Administration is for Quetiapine Fumarate tablet, generic version AstraZeneca's Seroquel is in strength of 25 mg (base).

"We expect to launch this product in Q4 FY14," the company said in a statement.

Quoting IMS data, the company said the current total market size for this product $59 million per annum.

As on September 30, 2013, Jubilant Life Sciences had a total of 676 filings for formulations of which 218 have been approved in various regions of the world. This includes 58 ANDAs filed in the US and 48 Dossier filings in Europe.

Shares of Jubilant Life Sciences closed at Rs 126.75 apiece, down 0.63% from their previous close on the BSE.