The approval granted by the US Food and Drug Administration (USFDA) is for doxepin hydrochloride capsules of strength 150 mg, the company said in a regulatory filing
Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic doxepin hydrochloride capsules used in the treatment of depression and anxiety. The approval granted by the US Food and Drug Administration (USFDA) is for doxepin hydrochloride capsules of strength 150 mg, the company said in a regulatory filing.
The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, it added. 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, it added. The drug had annual sales of $2.11 million in the US, the company said citing IQVIA MAT January 2023 data.