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New Drug Approvals Archive - October 2009

October 2009

Berinert (C1 esterase inhibitor (human)) Injection

Date of Approval: October 9, 2009
Company: CSL Behring
Treatment for: Angioedema

Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 esterase inhibitor indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients.

Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) Injection

Date of Approval: October 16, 2009
Company: GlaxoSmithKline
Treatment for: Human Papillomavirus Prophylaxis

Cervarix (human papillomavirus bivalent (types 16 and 18) is a is a preventative cervical cancer vaccine for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 in girls and young women (aged 10-25).

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)

New Indication Approved: October 16, 2009

Micardis (telmisartan)

New Indication Approved: October 16, 2009

Twynsta (telmisartan and amlodipine) Tablets

Date of Approval: October 16, 2009
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Treatment for: Hypertension

Twynsta (telmisartan/amlodipine) is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension alone or with other antihypertensive agents.

Votrient (pazopanib) Tablets

Date of Approval: October 19, 2009
Company: GlaxoSmithKline
Treatment for: Renal Cell Carcinoma, Soft Tissue Sarcoma

Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma and advanced soft tissue sarcoma.

Arzerra (ofatumumab) Injection

Date of Approval: October 26, 2009
Company: GlaxoSmithKline
Treatment for: Chronic Lymphocytic Leukemia

Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.

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