Zydus Lifesciences Gets USFDA Nod For Its Generic Depression, Anxiety Drug

Zydus Lifesciences Ltd. said it has received final approval from the US health regulator for its generic doxepin hydrochloride capsules used to treat depression and anxiety.

The U.S. Food and Drug Administration (USFDA) gave its approval for doxepin hydrochloride capsules of strength 150 mg, the company said in a regulatory filing on Friday.

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 health issues such as depression and anxiety. It improves mood and uplifts feelings of well-being; it relieves anxiety and tension. It also helps the patient sleep better and increases the energy level, it added.

The drug had annual sales of $2.11 million (Rs 17.37 crore) in the US, the company said, citing IQVIA MAT January 2023 data.