Unichem Labs bags USFDA nod for Bipolar disorder drug
New Delhi: Unichem Laboratories Limited today announced that the company has received Abbreviated New Drug Application (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).
The product is 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.
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 Goa Plant.
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Medical Dialogues team had earlier reported that the company had received approval from the United States Food and Drug Administration (USFDA) for its schizophrenia pill Aripiprazole Tablets. Aripiraprazole tablets are indicated for schizophrenia and irritability associated with autistic disorders.
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Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.
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