Zydus Lifesciences receives US FDA approval for antidepressant drugs

Zydus Lifesciences, a pharmaceutical company, stated that its Doxepin tablets have gained final approval from the US Food and Drug Administration (USFDA).

The company has acquired final approval to sell its Doxepin Tablets in 3 mg and 6 mg variants. The medication, which belongs to the class of tricyclic antidepressants, is used to treat sleep problems such as insomnia. The medication is intended to increase sleep duration and decrease nighttime awakenings.

According to a source provided by the company, Doxepin has yearly sales of $43.4 million in the United States. The medicines will be manufactured at the company's formulation production plant in Moraiya, Gujarat, according to the company.

With this latest approval, Zydus' total number of USFDA approvals now stands at 376. Since the beginning of the filing procedure in the fiscal year 2003-04, the company has filed over 444 abbreviated new medicine applications with the drug regulator.

Source: Media Reports