Zydus Cadila gets FDA approval for Fluphenazine Hydrochloride Tablets

Cadila Healthcare (also known as Zydus Cadila) said that it has secured final approval from the US Food and Drug Administration (FDA) to market Fluphenazine Hydrochloride Tablets 1 mg, 2.5 mg, 5 mg, and 10 mg.

The reference listed drug (RLD) of Zydus Cadila’ Fluphenazine Hydrochloride Tablets is Prolixin Tablets, which are indicated for the treatment of symptoms of a certain type of mental/mood condition (schizophrenia).

Zydus Cadila said that Fluphenazine comes under a class of medications called phenothiazines and is also referred to as a neuroleptic.

The Indian pharma company plans to manufacture Fluphenazine Hydrochloride Tablets at its formulation manufacturing facility in Ahmedabad.

Zydus Cadila gets FDA approval for Fluphenazine Hydrochloride Tablets. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

Zydus Cadila boasts 318 drug approvals and has filed more than 400 abbreviated new drug applications (ANDAs) to date since the start of the filing process in FY 2003-04.

Earlier this week, the company signed a license supply and commercialization deal with Taiwanese pharmaceutical company TLC to commercialize the latter’s AmphoTLC (Amphotericin B Liposome for Injection 50mg) for the treatment of Black Fungus in India.