New Drug Approvals Archive - August 2011
Anascorp (antivenom (centruroides scorpion)) Injection
Date of Approval: August 3, 2011
Anascorp (Centruroides (Scorpion) Immune F(ab’)2 (Equine)) is an antivenom indicated for treatment of clinical signs of scorpion envenomation.
Complera (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets
Date of Approval: August 10, 2011
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a combination of three antiretroviral medications indicated for the once daily treatment of HIV-1 infection in treatment-naïve adults.
Propel (mometasone furoate) Implant
Date of Approval: August 15, 2011
Propel (mometasone furoate) is a corticosteroid implant offering localized, controlled drug delivery for chronic sinusitis patients.
Zelboraf (vemurafenib) Tablets
Date of Approval: August 17, 2011
Zelboraf (vemurafenib) is a kinase inhibitor indicated for the treatment of patients with metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test.
Adcetris (brentuximab vedotin) Injection
Date of Approval: August 19, 2011
Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL).
New Indication Approved: August 24, 2011
Firazyr (icatibant) Injection
Date of Approval: August 25, 2011
Firazyr (icatibant) is a selective B2 bradykinin receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema.
New Dosage Form Approved: August 25, 2011
Xalkori (crizotinib) Capsules
Date of Approval: August 26, 2011
Xalkori (crizotinib) is an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive.
Artiss (fibrin sealant (human))
New Indication Approved: August 31, 2011
Adcetris (brentuximab vedotin)
Labeling Revision Approved: January 13, 2012