Mylan gets US approval for copy version of Astellas' immunosuppressant Prograf; Teva files complaint over Copaxone patents

22 September 2010

US generic drug major Mylan (Nasdaq: MYL) says that its subsidiary Mylan Pharmaceuticals has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for Tacrolimus Capsules, 0.5mg, 1mg and mg, the generic version of Japanese drugmaker Astellas' best-selling product, Prograf, a treatment to prevent rejection in people who have received certain organ transplants.

Tacrolimus capsules had US sales of around $944 million for the 12 months ending June 30, 2010, according to IMS Health. Mylan said it would launch its copy product immediately.

When Astellas reported its first-quarter fiscal 2011 results, the company revealed that generic competition in the USA had eroded sales of Prograf, which globally declined 16.5% for the period (The Pharma Letter August 4).

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

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