New Drug Approvals Archive
New Drug Approvals: June 2006
| June 1 | 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. Orapred ODT BioMarin Pharmaceutical Inc./Alliant Pharmaceuticals, Inc. - Treatment for Asthma and other Inflammatory Conditions in Children |
| June 5 | Juvederm (hyaluronic acid gel) Date of Approval: June 5, 2006 Company: Allergan, Inc. Treatment for Facial Wrinkles and Folds Juvederm gel is a hyaluronic acid dermal filler indicated for the correction of facial wrinkles and folds. Juvederm Allergan, Inc. - Treatment for Facial Wrinkles and Folds |
| June 8 | Advair HFA GlaxoSmithKline - Treatment for Asthma |
| June 8 | Gardasil (human papillomavirus vaccine) 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 cancer, cervical pre-cancers, vulvar pre-cancers and vaginal pre-cancers caused by HPV types 16 and 18. Gardasil is also approved for the prevention of genital warts and low-grade cervical lesions caused by HPV types 6, 11, 16 and 18. Gardasil is approved for 9- to 26-year-old girls and women. Gardasil Merck & Co., Inc. - Treatment for Prevention of Cervical Cancer other HPV-related Diseases |
| June 14 | Zelapar (selegiline hydrochloride) Orally Disintegrating Tablets Company: Valeant Pharmaceuticals International Treatment for Parkinson’s Disease Zelapar Valeant Pharmaceuticals International - Treatment for Parkinson’s Disease |
| June 22 | 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. Opana ER Endo Pharmaceuticals Inc. - Treatment for Moderate-to-Severe Pain |
| June 23 | Prezista (darunavir) Tablets - formerly TMC114 Date of Approval: December 31, 1969 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. Prezista Tibotec Pharmaceuticals Ltd. - Treatment for Human Immunodeficiency Virus (HIV) |
| June 28 | Sprycel (dasatinib) Tablets Company: Bristol-Myers Squibb Company Treatment for Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) Sprycel Bristol-Myers Squibb Company - Treatment for Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) |
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