The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). INTELENCE is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents. The traditional approval is based on 48-week data from two Phase 3 studies known as DUET-1 and DUET-2.

Organon has announced the launch in India of its vaginal ring that contains the same hormones found in the oral pill, but is to be self-inserted only once-a-month for contraceptive action. The ring was approved by the US Food and Drug Administration in 2001. The Central Drugs Control Standards Organisation (CDSCO) in New Delhi approved the contraceptive ring for marketing in India in 2005.

CSL Behring has announced that the FDA has granted marketing approval for Berinert® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE).  Berinert is the first therapy approved for this indication in the U.S. The approval is based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor concentrate.

Angiotech Pharmaceuticals, Inc. has launched the Tan EndoGlide(TM) Endothelium Insertion System in the United States. Angiotech holds exclusive U.S. distribution rights to market and distribute the Tan EndoGlide Endothelium Insertion System. The Tan EndoGlide is a device used to facilitate insertion of a donor endothelium during Endothelial Keratoplasty. The device is used by Ophthalmologists adapting to newer techniques to replace diseased corneal endothelium.