US generic drug major Mylan (Nasdaq: MYL) revealed last Friday that it has begun shipping its generic version of the lipid-lowerer Lescol (fluvastatin), after its subsidiary Mylan Pharmaceuticals received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for fluvastatin capsules USP, 20mg and 40mg, the first generic copy of the branded product from Swiss pharma major Novartis (NOVN: VX).
This product is indicated for the treatment of both familial and non-familial hypercholesterolemia and mixed dyslipidemia. It is also indicated for the secondary prevention of cardiovascular disease. The Lescol brand generated US sales of $27.9 million in 2011.
Under a settlement and license deal with Novartis, Mylan was granted rights to launch a copy of fluvastatin prior to the expiration of the pediatric exclusivity associated with US Patent No 5,356,896, which expires on June 12, 2012.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze