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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.

Read more: Berinert (C1 esterase inhibitor (human)) FDA Approval History

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).

Read more: Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) FDA Approval History

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

New Indication Approved: October 16, 2009

Read more: Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) FDA Approval History

Fluarix (influenza virus vaccine, inactivated)

Patient Population Altered: October 19, 2009

Read more: Fluarix (influenza virus vaccine, inactivated) FDA Approval History

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.

Read more: Twynsta (telmisartan and amlodipine) FDA Approval History

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.

Read more: Votrient (pazopanib) FDA Approval History

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.

Read more: Arzerra (ofatumumab) FDA Approval History

New Drug Approvals Archive