New Drug Approvals Archive
New Drug Approvals: December 2006
| December 1 | Alaway (ketotifen ophthalmic) Solution Date of Approval: December 1, 2006 Company: Alimera Sciences Inc. Treatment for: Seasonal Allergic Conjunctivitis Alaway (ketotifen) is an over-the-counter ophthalmic antihistamine indicated for the temporary relief of itchy eyes associated with pollen, ragweed, grass, animal hair and dander. Alaway Itchy Eyes - Treatment for Itchy Eyes |
| December 15 | Cyanokit (hydroxocobalamin) Injection Date of Approval: December 15, 2006 Company: EMD Pharmaceuticals and Dey, LP Treatment for: Cyanide Poisoning Cyanokit contains hydroxocobalamin, an antidote indicated for the treatment of known or suspected cyanide poisoning. Cyanokit EMD Pharmaceuticals and Dey, LP - Treatment for Cyanide Poisoning |
| December 15 | Elestrin (estradiol) Gel - formerly Bio-E-Gel Date of Approval: December 15, 2006 Company: BioSante Pharmaceuticals, Inc. Treatment for: Postmenopausal Symptoms Elestrin is a fast-drying transdermal gel formulation of bio-identical estradiol indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. Elestrin BioSante Pharmaceuticals, Inc. - Treatment for Menopausal Vasomotor Symptoms |
| December 19 | Invega (paliperidone) Date of Approval: December 19, 2006 Company: Janssen, L.P. Treatment for: Schizophrenia Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder. Invega Sustenna is an extended-release injectable formulation of paliperidone administered once-monthly for the acute and maintenance treatment of schizophrenia. Invega Approved By FDA as New Treatment for Schizophrenia |
| December 22 | Radiesse (dermal filler) Dermal Filler Date of Approval: December 22, 2006 Company: BioForm Medical, Inc Treatment for: Wrinkle Correction Radiesse is a cosmetic dermal filler, for the long-lasting correction of moderate to severe facial wrinkles and folds. Radiesse BioForm Medical, Inc - Treatment for Moderate to Severe Facial Wrinkles |
| December 19 | Invega (paliperidone) Date of Approval: December 19, 2006 Company: Janssen, L.P. Treatment for: Schizophrenia Invega (paliperidone) is a once-daily oral atypical antipsychotic indicated for the acute and maintenance treatment of schizophrenia, and the acute treatment of schizoaffective disorder. Invega Sustenna is an extended-release injectable formulation of paliperidone administered once-monthly for the acute and maintenance treatment of schizophrenia. FDA Approves Invega for Long-Term Maintenance Treatment of Schizophrenia |
| August 3 | Invega (paliperidone)
New Dosage Form Approved: July 31, 2009 FDA Approves Invega Sustenna for the Acute and Maintenance Treatment of Schizophrenia |
| August 6 | Invega (paliperidone)
New Indication Approved: July 31, 2009 Invega Approved as the First and Only Treatment for Schizoaffective Disorder |
New Drug Approvals Archive
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