Zydus Lifesciences Depression drug Doxepin Hydrochloride bags USFDA okay

Ahmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the company has received final approval for Doxepin Hydrochloride Capsules USP, 150 mg (USRLD: Sinequan Capsules) from the United States Food and Drug Administration (USFDA).

Doxepin Hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety. It helps improve moods and feelings of well-being, relieves anxiety and tension, helps sleep better and increases the energy level.

The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad, India).

Doxepin Hydrochloride Capsules USP, 150 mg had annual sales of USD 2.11 mn in the United States (IQVIA MAT Jan. 2023). The group now has 353 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported that Zydus Lifesciences had received final approval from the USFDA to manufacture and market Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg (USRLD: Zyprexa Zydis Orally Disintegrating Tablets).

Read also: Zydus bags USFDA nod for Olanzapine Orally Disintegrating Tablets to treat certain mental conditions