Zydus Lifesciences bags Doxepin Tablets FDA approval for insomnia

Zydus Lifesciences Limited has secured a pivotal nod from the United States Food and Drug Administration (USFDA) for its Doxepin Tablets, available in 3 mg and 6 mg dosages. These tablets, which correspond to the US Reference Listed Drug (RLD) Silenor Tablets, serve as a remedy for insomnia, aiming to prolong sleep duration and minimize nightly disturbances.

As a member of the tricyclic antidepressants class, Doxepin holds the promise of ameliorating sleep problems for countless patients. The medication will see production at Zydus’s formulation manufacturing facility located in Moraiya.

Industry data suggests a robust market presence for Doxepin Tablets, with sales touching $43.4 million in the US as of June 2023 (as reported by IQVIA MAT). This new approval boosts Zydus’s pharmaceutical repertoire, taking its total to 376 approved drugs. Furthermore, the firm has been actively contributing to the pharmaceutical landscape, boasting over 444 abbreviated new drug application (ANDA) filings since the 2003-04 fiscal year.