Zydus Cadila Announced First Approval for Transdermal Product in US

| By | Alzheimer's, FDA Approved, Indian Pharma, Parkinson’s

Zydus Cadila has received the approval from the 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 Ltd., the group’s manufacturing facility dedicated to the production of transdermals, located at SEZ, Ahmedabad.

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 ANDAs since the commencement of the filing process in FY 2003-04

SOURCE: Zydus Cadila
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