New Drug Approvals Archive - May 2011
New Indication Approved: April 29, 2011
Patient Population Altered: April 29, 2011
Tradjenta (linagliptin) Tablets
Date of Approval: May 2, 2011
Tradjenta (linagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
New Indication Approved: May 6, 2011
Fluzone (influenza virus vaccine, inactivated)
New Formulation Approved: May 9, 2011
Date of Approval: May 13, 2011
Victrelis (boceprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C.
Edurant (rilpivirine) Tablets - formerly TMC278
Date of Approval: May 20, 2011
Edurant (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve).
Sutent (sunitinib malate)
New Indication Approved: May 20, 2011
Incivek (telaprevir) Tablets
Date of Approval: May 23, 2011
Incivek (telaprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of chronic hepatitis C (CHC).
Date of Approval: May 27, 2011
Dificid (fidaxomicin) is a macrolide antibacterial drug indicated for the treatment of Clostridium difficile-associated diarrhea.
Labeling Revision Approved: August 13, 2012