Zydus Cadila receives USFDA’s nod for Rivastigmine Transdermal System

05 Mar 2019 Evaluate

Zydus Cadila has received the approval from the US Food and Drug Administration (USFDA) to market Rivastigmine Transdermal System (US RLD - EXELON PATCH), 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, marking its first approval for a transdermal product in the US. It is indicated for the treatment of dementia (memory loss) associated with Alzheimer’s and Parkinson’s diseases. It will be manufactured at Zydus Technologies, the group’s manufacturing facility dedicated to the production of transdermals, located at SEZ, Ahmedabad in the state of Gujarat.

The group also received the final approval for Rosuvastatin Tablets USP (US RLD - Crestor) in the strengths of 5 mg, 10 mg, 20 mg, and 40 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

Rosuvastatin belongs to a group of drugs known as statins. It works by reducing the amount of cholesterol made by the liver. Lowering bad cholesterol and triglycerides and raising good cholesterol decreases the risk of heart disease and helps to prevent strokes and heart attacks. Rosuvastatin is used along with a proper diet to help lower bad cholesterol (such as LDL, triglycerides) and raise good cholesterol (HDL) in the blood.

The group now has 252 approvals and has so far filed over 350 ANDA’s 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.

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