Zydus Lifesciences secures USFDA approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg
Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg (USRLD: Sinequan Capsules) from the United States Food and Drug Administration (USFDA).
Doxepin Hydrochloride capsule is recommended for the treatment of Psychoneurotic patients with depression and/or anxiety, Depression and/or anxiety associated with alcoholism and organic disease, and Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg had annual sales of USD 28.9 mn in the United States (IQVIA MAT Jan. 2023). The group now has 355 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 the company had received final USFDA approval for Doxepin Hydrochloride Capsules USP, 150 mg (USRLD: Sinequan Capsules).
Read also: Zydus Lifesciences Depression drug Doxepin Hydrochloride bags USFDA okay
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.
Read also: Zydus bags USFDA nod for Olanzapine Orally Disintegrating Tablets to treat certain mental conditions
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