Mylan gets final US FDA approval for felodipine extended-release tabs
Mylan Pharmaceuticals Inc, a quality generic and specialty pharmaceutical company, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Felodipine extended-release tablets USP, 2.5 mg, 5 mg and 10 mg, which will be shipping immediately.
Felodipine extended-release tablets USP are the generic version of AstraZeneca Pharmaceutical's Plendil extended-release tablets, which had US sales of approximately $251 million for the 12 months ending Dec. 31, 2007, according to IMS Health.