New Drug Approvals Archive

Get news by email or subscribe to our news feeds.

October 2009

October 2

Mirena (levonorgestrel)

New Indication Approved: October 1, 2009

October 7

Welchol (colesevelam)

Patient Population Altered: October 2, 2009

October 9

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.

Berinert (C1 esterase inhibitor (human)) FDA Approval History

October 16

Crestor (rosuvastatin calcium)

Patient Population Altered: October 15, 2009

October 16

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).

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

October 16

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

New Indication Approved: October 16, 2009

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

October 16

Elitek (rasburicase)

Patient Population Altered: October 16, 2009

October 19

Fluarix (influenza virus vaccine, inactivated)

Patient Population Altered: October 19, 2009

Fluarix (influenza virus vaccine, inactivated) FDA Approval History

October 19

Micardis (telmisartan)

New Indication Approved: October 16, 2009

October 16

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.

Twynsta (telmisartan and amlodipine) FDA Approval History

October 19

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.

Votrient (pazopanib) FDA Approval History

October 22

Colcrys (colchicine)

New Indication Approved: October 16, 2009

Colcrys (colchicine) FDA Approval History

October 26

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.

Arzerra (ofatumumab) FDA Approval History

January 3

Berinert (C1 esterase inhibitor (human))

New Indication Approved: December 22, 2011

Berinert (C1 esterase inhibitor (human)) FDA Approval History

April 26

Votrient (pazopanib)

New Indication Approved: April 26, 2012

Votrient (pazopanib) FDA Approval History

Hide
(web2)