Zydus Cadila receives USFDA nod for Fluphenazine Hydrochloride Tablets

Zydus Cadila on Saturday said it has received final approval from the US health regulator to market Fluphenazine Hydrochloride Tablets in the US. This medication is used to treat symptoms of a certain type of mental/mood condition (schizophrenia).

The Company in a regulatory filing today said, the company has received approval from the US Food and Drug Administration (USFDA) to market Fluphenazine Hydrochloride Tablets in the strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg (US RLD: Prolixin Tablets) in the US.

Fluphenazine belongs to a class of medications called phenothiazines and is also referred to as a neuroleptic.

The company said, the drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 318 approvals and has so far filed over 400 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs nearly 25000 people worldwide and is dedicated to creating healthier communities globally.