New Drug Approvals: June 2006

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.

Date of Approval: June 2, 2006

Company: Allergan, Inc.

Treatment for Wrinkle Correction

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

Date of Approval: June 8, 2006

Company: Merck & Co., Inc.

Treatment for Human Papillomavirus Prophylaxis

Gardasil is a recombinant vaccine indicated for the prevention of cervical, vulvar, and vaginal cancers caused by human papillomavirus in girls and women 9 through 26 years of age.

Company: Valeant Pharmaceuticals International

Treatment for Parkinson’s Disease

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.

Date of Approval: June 23, 2006

Company: Tibotec Pharmaceuticals Ltd.

Treatment for HIV Infection

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

Company: Bristol-Myers Squibb Company

Treatment for Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)