Jubilant received FDA approval for antipsychotic drug
The drug is used in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder.
New Delhi, November 28, 2013: Jubilant Life Sciences Ltd has received approval from the US health regulator to market the generic version of AstraZeneca's Seroquel used for the treatment of schizophrenia and acute manic episodes associated with bipolar disorder.
It is important to note that the abbreviated new drug applications (ANDAs) approval from the US Food and Drug Administration (USFDA) is for QuetiapineFumarate tablet, generic version AstraZeneca's Seroquel is in strength of 25 mg (base).
The company is expecting to launch the product in Q4 FY14. The company also said that the total market size for this product stands at US$ 59 million per annum.
The company so far has a total of 676 filings for formulations of which 218 have been approved in various regions of the world. The approvals include 58 ANDAs filed in the US and 48 dossier filings in Europe.