Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Doxepin Tablets, 3 mg and 6 mg (USRLD: Silenor Tablets, 3 mg and 6 mg). Doxepin is used to treat a certain sleep problem (insomnia). It is expected to help stay asleep longer and reduce the number of times a person wakes up during the night. Doxepin belongs to a class of drugs known as tricyclic antidepressants. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya.
Doxepin Tablets, 3 mg and 6 mg had annual sales of $43.4 million in the United States (IQVIA MAT June 2023). The group now has 376 approvals and has so far filed over 444 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
