Mylan Receives Tentative FDA Approval for Generic Lipitor
Mylan announced that the FDA has granted tentative approval for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium tablets. Atorvastatin Calcium is the generic equivalent for Lipitor (Pfizer), indicated for the prevention and risk reduction of cardiovascular disease (eg, myocardial infarction, stroke, revascularization procedures, hospitalization for CHF, angina) and hypercholesterolemia (eg, heterozygous familial and nonfamilial hypercholesterolemia, mixed dyslipidemia, primary dysbetalipoproteinemia).
Pending the final approval, Mylan is expected to make available Atorvastatin Calcium in 10mg, 20mg, 40mg, and 80mg dosage strength tablets.
For more information call (800) RX-MYLAN or visit www.mylan.com.