Mylan nets FDA approval to market generic Lipitor

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

Mylan's subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the FDA for its abbreviated New Drug Application (ANDA) for atorvastatin calcium tablets.

The newly approved doses are 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base), according to the Pittsburgh-based Mylan.

Atorvastatin calcium is the generic equivalent to Pfizer's Lipitor, indicated for the prevention of cardiovascular disease and hypercholesterolemia.