Unichem Lab receives USFDA approval for Quetiapine Extended-Release Tablets

16 Aug 2022 , 01:43 PM

Unichem Laboratories Limited has received ANDA approval for its Quetiapine Extended-Release Tablets USP, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg from the United States Food and Drug Administration (USFDA) to market a generic version of SEROQUEL XR (Quetiapine) Tablet, Extended Release, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg of AstraZeneca Pharmaceuticals LP.

According to the filing, Quetiapine Extended-Release tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD). The product will be commercialized from Unichem’s plant situated at Goa, the company said.

At around 1:44 PM, Unichem Laboratories Ltd was currently trading at Rs277.45 per share down by Rs1.85 or 0.66% from its previous closing of Rs279.30 per share on the BSE.