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New Drug Approvals Archive - August 2011

See also: New Indications and Dosage Forms for 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.

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.

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.

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.

Adcetris (brentuximab vedotin) Injection

Date of Approval: August 19, 2011
Company: Seattle Genetics, Inc.
Treatment for: Lymphoma, Hodgkin's Disease, Mycosis Fungoides

Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of adult patients with:

  • Previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.
  • Classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
  • Classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates.
  • Previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
  • Systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
  • Primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30- expressing mycosis fungoides (MF) who have received prior systemic therapy.

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.

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.

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