FDA actions

FDA actions

The FDA approved generic atorvastatin (Lipitor) on November 30, 2011. Ranbaxy Laboratories will make the first generic in 10, 20, 40, and 80 mg strengths. Atorvastatin as Lipitor was first marketed in 1997 and became the best-selling prescription medication in history with sales of more than $125 billion. It has dominated the statin market in recent years, representing nearly a quarter of Pfizer's annual revenue, and the giant pharmaceutical company aggressively defended their patent against multiple challenges. Ranbaxy has 180 days of exclusivity on generic atorvastatin after which time multiple manufacturers are expected to seek approval for their generic version of the drug.

The FDA has approved Prevnar 13 for adults age 50 and older to prevent pneumonia and invasive disease caused by Streptococcus pneumoniae. The vaccine was previously approved for children up to 5 years of age. The approval was based on head-to-head studies with Pneumovax 23 which is already approved for use in adults. According to the FDA, "for the 12 common serotypes, Prevnar 13-induced antibody levels were either comparable to or higher than the levels induced by Pneumovax 23." Prevnar 13 is manufactured by Wyeth Pharmaceuticals.

Dronedarone (Multaq) should not be prescribed to patients with permanent atrial fibrillation (AF), based on results from the PALLAS trial which showed that the drug doubles the risk for cardiovascular death, stroke, and heart failure in such patients. The FDA is requiring revised labeling for the antiarrhythmic drug and has issued a Drug Safety Communication after a safety review was completed. If dronedarone is to be prescribed, the FDA recommends ECGs every 3 months and immediately stopping the drug if the patient is found to be in AF. The drug is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (paroxysmal or persistent AF). Dronedarone is manufactured by Sanofi-Aventis.