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New Drug Approvals Archive - June 2006

June 2006

Orapred ODT (prednisolone sodium phosphate) Orally Disintegrating Tablets

Date of Approval: June 1, 2006
Company: BioMarin Pharmaceutical Inc./Alliant Pharmaceuticals, Inc.
Treatment for: Asthma -- Acute

Orapred ODT is an orally disintegrating tablet formulation of prednisolone, used to treat exacerbations of asthma and other inflammatory diseases and conditions in children. Orapred ODT tablets are grape flavored and can be swallowed whole or allowed to dissolve in the mouth, with or without the assistance of water.

Juvederm (dermal filler)

Date of Approval: June 2, 2006
Company: Allergan, Inc.
Treatment for: Facial Rejuvenation

Juvederm is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.

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

Date of Approval: June 8, 2006
Company: Merck & Co., Inc.
Treatment for: Human Papillomavirus Prophylaxis

Gardasil (human papillomavirus vaccine) is a recombinant vaccine indicated for the prevention of cervical, vulvar, and vaginal cancers caused by human papillomavirus (HPV) in girls and women 9 through 26 years of age. Gardasil is also approved for the prevention of genital warts caused by HPV types 6 and 11 in boys and men 9 through 26 years of age.

Zelapar (selegiline hydrochloride) Orally Disintegrating Tablets

Date of Approval: June 14, 2006
Company: Valeant Pharmaceuticals International
Treatment for: Parkinson's Disease

Zelapar (selegiline) is an an irreversible inhibitor of monoamine oxidase (MAO) indicated as an adjunct in the management of patients with Parkinson’s disease.

Opana (oxymorphone) Tablets and ER Tablets

Date of Approval: June 22, 2006
Company: Endo Pharmaceuticals Inc.
Treatment for: Pain

Opana ER (extended-release) and Opana (immediate-release) are oral formulations of the opioid analgesic oxymorphone, used for the relief of moderate-to-severe pain. Opana ER is indicated for patients requiring continuous, around-the-clock opioid treatment for an extended period of time, and Opana is indicated for the relief of acute pain where the use of an opioid is appropriate.

Prezista (darunavir) Tablets - formerly TMC114

Date of Approval: June 23, 2006
Company: Janssen Therapeutics
Treatment for: HIV Infection

Prezista (darunavir) is a protease inhibitor used with ritonavir in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection.

Sprycel (dasatinib) Tablets

Date of Approval: June 28, 2006
Company: Bristol-Myers Squibb Company
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Lucentis (ranibizumab) Injection

Date of Approval: June 30, 2006
Company: Genentech, Inc.
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

Lucentis (ranibizumab) is a humanized anti-VEGF antibody fragment indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

Sprycel (dasatinib) Tablets

Date of Approval: June 28, 2006
Company: Bristol-Myers Squibb Company
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia

Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.

Juvederm (dermal filler)

Date of Approval: June 2, 2006
Company: Allergan, Inc.
Treatment for: Facial Rejuvenation

Juvederm is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.

Juvederm (dermal filler)

Date of Approval: June 2, 2006
Company: Allergan, Inc.
Treatment for: Facial Rejuvenation

Juvederm is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds.

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