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New Drug Approvals Archive - August 2011

August 2011

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.

Read more: Anascorp (antivenom (centruroides scorpion)) FDA Approval History

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.

Read more: Complera (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) FDA Approval History

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.

Read more: Propel (mometasone furoate) FDA Approval History

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, and for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.

Read more: Zelboraf (vemurafenib) FDA Approval History

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).

Read more: Adcetris (brentuximab vedotin) FDA Approval History

Botox (onabotulinumtoxinA)

New Indication Approved: August 24, 2011

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.

Read more: Firazyr (icatibant) FDA Approval History

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.

Read more: Xalkori (crizotinib) FDA Approval History

New Drug Approvals Archive