Mylan believes that it is the first company to file a substantially complete abbreviated new drug application (ANDA) containing a paragraph IV certification for the product.
The company has filed an ANDA with the FDA in June 2008. Novartis has filed a lawsuit in the US District Court of New Jersey alleging infringement of US patent.
Fluvastatin capsules are used in the treatment of high cholesterol. Currently, Mylan has 108 ANDAs pending FDA approval, 22 of which are potential first-to-file opportunities.