New Drug Approvals Archive

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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.

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.

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.

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 BRAFV600E mutation as detected by an FDA-approved test.

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).

Adcetris (brentuximab vedotin) FDA Approval History

August 24

Botox (onabotulinumtoxinA)

New Indication Approved: August 24, 2011

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.

Firazyr (icatibant) FDA Approval History

August 26

Nucynta (tapentadol)

New Dosage Form Approved: August 25, 2011

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 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.

Xalkori (crizotinib) FDA Approval History

August 31

Artiss (fibrin sealant (human))

New Indication Approved: August 31, 2011

Artiss (fibrin sealant (human)) FDA Approval History

January 13

Adcetris (brentuximab vedotin)

Labeling Revision Approved: January 13, 2012

Adcetris (brentuximab vedotin) FDA Approval History

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