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New Drug Approvals Archive - August 2011

August 2011

August 3	Anascorp (antivenom (centruroides scorpion)) Injection Date of Approval: August 3, 2011 Treatment for: Scorpion Stings Anascorp (Centruroides (Scorpion) Immune F(ab’)2 (Equine)) is an antivenom indicated for treatment of clinical signs of scorpion envenomation. FDA Approves Anascorp - First Specific Treatment for Scorpion Stings Anascorp (antivenom (centruroides scorpion)) FDA Approval History
August 10	Complera (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets Date of Approval: August 10, 2011 Company: Gilead Sciences, Inc. Treatment for: HIV Infection 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. U.S. Food and Drug Administration Approves Gilead Sciences' Complera, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naïve Adults Complera (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) FDA Approval History
August 15	Propel (mometasone furoate) Implant Date of Approval: August 15, 2011 Company: Intersect ENT, Inc. Treatment for: Sinusitis Propel (mometasone furoate) is a corticosteroid implant offering localized, controlled drug delivery for chronic sinusitis patients. Intersect ENT Announces U.S. Food and Drug Administration Approval for Propel - First Drug Releasing Implant for Chronic Sinusitis Patients Propel (mometasone furoate) FDA Approval History
August 17	Zelboraf (vemurafenib) Tablets Date of Approval: August 17, 2011 Company: Genentech, Inc. Treatment for: Melanoma - Metastatic Zelboraf (vemurafenib) is a kinase inhibitor indicated for the treatment of patients with metastatic melanoma with BRAF^V600E mutation as detected by an FDA-approved test. FDA Approves Zelboraf and Companion Diagnostic Test for Late-Stage Skin Cancer Zelboraf (vemurafenib) FDA Approval History
August 19	Adcetris (brentuximab vedotin) Injection Date of Approval: August 19, 2011 Company: Seattle Genetics, Inc. Treatment for: Lymphoma, Hodgkin's Disease 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). FDA Approves Adcetris to Treat Two Types of Lymphoma Adcetris (brentuximab vedotin) FDA Approval History
August 24	Botox (onabotulinumtoxinA) New Indication Approved: August 24, 2011 FDA Approves Botox to Treat Specific Form of Urinary Incontinence
August 25	Firazyr (icatibant) Injection Date of Approval: August 25, 2011 Company: Shire plc Treatment for: Angioedema Firazyr (icatibant) is a selective B2 bradykinin receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema. FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE) Firazyr (icatibant) FDA Approval History
August 26	Nucynta (tapentadol) New Dosage Form Approved: August 25, 2011 Nucynta ER (Tapentadol Extended-Release Tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain Nucynta (tapentadol) FDA Approval History
August 26	Xalkori (crizotinib) Capsules Date of Approval: August 26, 2011 Company: Pfizer Inc. Treatment for: Non-Small Cell Lung Cancer Xalkori (crizotinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive. FDA Approves Xalkori with Companion Diagnostic for a Type of Late-Stage Lung Cancer Xalkori (crizotinib) FDA Approval History
August 31	Artiss (fibrin sealant (human)) New Indication Approved: August 31, 2011 Baxter Announces FDA Approval of Artiss Fibrin Sealant for Use in Face-Lift (Facial Rhytidectomy) Procedures Artiss (fibrin sealant (human)) FDA Approval History
January 13	Adcetris (brentuximab vedotin) Labeling Revision Approved: January 13, 2012 Seattle Genetics Announces Updates to Adcetris Prescribing Information Adcetris (brentuximab vedotin) FDA Approval History
March 11	Xalkori (crizotinib) New Indication Approved: March 11, 2016 FDA Expands Use of Xalkori (crizotinib) to Treat ROS-1 Positive Non-Small Cell Lung Cancer Xalkori (crizotinib) FDA Approval History

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