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news.Generic specialist Mylan Laboratories has been granted tentative approval for its copycat version of GlaxoSmithKline's heart drug Coreg.
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The FDA’s decision means that Mylan’s application is in order and the product will be approved pending patent expiry or legal issues surrounding the original drug. The drugs are a type of beta-blocker that work by lowering the hormones that increase blood pressure.
Mylan’s application is for four different strengths of Carvedilol tablets, the generic version of the Coreg Tablets, which had annual US sales of approximately $1.14 billion as of December 2005.
The FDA also recently approved a generic version of Glaxo’s top selling nasal spray, Flonase, to be sold by Roxane Laboratories, a subsidiary of Boehringer Ingelheim. Glaxo’s blockbuster antihistamine is designed to relieve the symptoms of allergic and non-allergic rhinitis and achieved sales of $881.7 million last year.