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 2 | Juvederm (dermal filler) 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. Juvederm Allergan, Inc. - Treatment for Facial Wrinkles and Folds |
| June 8 | 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. FDA Approves Gardasil for Prevention of Cervical Cancer other HPV-related Diseases |
| 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: June 23, 2006 Company: Tibotec Pharmaceuticals Ltd. 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. Prezista Tibotec Pharmaceuticals Ltd. - Treatment for Human Immunodeficiency Virus (HIV) |
| June 28 | Sprycel (dasatinib) Tablets Date of Approval: June 28, 2006 Company: Bristol-Myers Squibb Company Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Sprycel Bristol-Myers Squibb Company - Treatment for Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) |
| June 28 | Sprycel (dasatinib) Tablets Date of Approval: June 28, 2006 Company: Bristol-Myers Squibb Company Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia Sprycel (dasatinib) is a kinase inhibitor indicated for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. FDA Approves New Sprycel (Dasatinib) Product Labeling for Patients with Chronic-Phase CML |
| September 15 | Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)
New Indication Approved: September 12, 2008 FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers |
| October 22 | Prezista (darunavir)
Patient Population Altered: October 21, 2008 U.S. Food and Drug Administration (FDA) Approves Prezista Once-Daily as Part of Combination Therapy for Treatment-Naive Adults with HIV-1 |
| May 26 | Sprycel (dasatinib)
Labeling Revision Approved: May 21, 2009 FDA Grants Full Approval for Sprycel (dasatinib) for the Treatment of Adults with Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Prior Therapies Including Gleevec |
| October 16 | Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant)
New Indication Approved: October 16, 2009 FDA Approves Gardasil for Use in Boys and Young Men |
New Drug Approvals Archive
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