Pfizer said the FDA has approved new labeling of Sutent (sunitinib malate) which includes first-line treatment of advanced renal cell carcinoma, a type of advanced kidney cancer, based on results of a large Phase III trial, which showed prolonged progression-free survival.
Mylan Laboratories and Barr Pharmaceuticals became the second and third drugmakers to receive FDA approval to sell generic versions of Pfizer’s blockbuster antidepressant Zoloft (sertraline). Both companies said they would begin shipping the product immediately. Pfizer lost patent protection on Zoloft last August. Branded Zoloft sales fell 79% in Pfizer’s fourth quarter to $166 million, compared with $808 million in the same period a year earlier. Teva Pharmaceutical was able to sell the only generic version during the first six months after expiration of Zoloft’s patent, under a federally enforced exclusivity period.