Pfizer Receives Complete Response Letter from FDA for REMOXY
CUPERTINO, Calif., June 24, 2011 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today reported that Pfizer Inc. (NYSE: PFE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY , a controlled-release form of oxycodone designed to discourage common methods of tampering. Pfizer stated that it is working to ...

FDA Approves NULOJIX (belatacept)
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration approved NULOJIX, the first selective T-cell costimulation blocker indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil , and corticosteroids.

FDA urges caution for silicone breast implant recipients
Women with silicone breast implants need to know that they probably will not last forever and might need to be removed or replaced within a decade of implantation, according to a report released yesterday by the US Food and Drug Administration. About 20 percent of women who have silicone implants for breast augmentation will have problems that warrant ...