Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (US FDA) for Quetiapine Fumarate tablet, 25 mg (base), the generic version of AstraZeneca’s Seroquel, which is an atypical antipsychotic medication indicated for the treatment of schizophrenia, and for the treatment of acute manic episodes associated with bipolar disorder.
The current total market size for this product as per IMS is $59 million per annum. This product is expected to be launched in Q4 FY14. 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.
EP News Bureau – Mumbai