FDA Actions in Brief June 2011 (Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev)

June 1, 2011

Recent FDA Approvals (through May 2011) related to Incivek, Victrelis, Edurant, Sutent, Argatroban injection, Afinitor, Tradjenta, Fusilev

Telaprevir (Incivek, Vertex) tablets were approved for a broad group of people with genotype 1 chronic hepatitis C (CHC) with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis.

Boceprevir (Victrelis, Merck) was approved for the treatment of genotype 1 CHC infection, in combination with peginterferon alfa and ribavirin, in adult patients (aged 18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

Rilpivirine (Edurant, Tibotec Therapeutics, a division of Centocor Ortho Biotech) in combination with other antiretroviral drugs was approved for the treatment of HIV-1 infection in adults who have never taken HIV therapy.

Argatroban injection (in sodium chloride) (Sandoz), the first ready-to-use alternative to concentrate formulation, was approved as an anticoagulant for the prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia.

Everolimus (Afinitor, Novartis) was approved for the treatment of patients with progressive neuroendocrine tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body.

Linagliptin (Tradjenta, Boehringer Ingelheim) tablets were approved, used with diet and exercise, to improve blood glucose control in adults with type 2 diabetes.

An expanded use of levoleucovorin (Fusilev, Spectrum Pharmaceuticals) was approved for patients with advanced metastatic colorectal cancer. This new indication of Fusilev where it will be used in combination with 5-fluorouracil, supplements the original 2008 FDA approval of the drug.