New Drug Approvals Archive
New Drug Approvals: May 2009
| May 1 | Cetraxal (ciprofloxacin otic) Solution Date of Approval: May 1, 2009 Company: Salvat Treatment for: Otitis Externa Cetraxal (ciprofloxacin otic) is an antibiotic ear solution for the treatment of acute otitis externa. FDA Approves Cetraxal Otic Solution |
| May 6 | Avastin (bevacizumab)
New Indication Approved: May 5, 2009 FDA Grants Accelerated Approval of Avastin for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy |
| May 5 | Cycloset (bromocriptine mesylate) Tablets Date of Approval: May 5, 2009 Company: VeroScience and S2 Therapeutics, Inc. Treatment for: Diabetes Mellitus Type II Cycloset (bromocriptine) is a first-in-class, central acting agent for the treatment of Type 2 Diabetes. VeroScience Announces FDA Approval of Cycloset for Treatment of Type 2 Diabetes |
| May 6 | Fanapt (iloperidone) Tablets Date of Approval: May 6, 2009 Company: Vanda Pharmaceuticals Inc. Treatment for: Schizophrenia Fanapt (iloperidone) is a 5HT2/D2 antagonist (atypical) antipsychotic for the treatment of schizophrenia. FDA Approves Fanapt to Treat Schizophrenia |
| May 11 | Lamictal (lamotrigine)
New Dosage Form Approved: May 8, 2009 FDA Approves Lamictal ODT Orally Disintegrating Tablets |
| May 13 | Azor (amlodipine and olmesartan)
New Indication Approved: May 11, 2009 Azor Receives FDA Approval as First-Line Treatment for High Blood Pressure |
| May 13 | ACTOplus met (pioglitazone and metformin)
New Dosage Form Approved: May 12, 2009 FDA Approves ACTOplus met XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes |
| May 13 | Cimzia (certolizumab pegol)
New Indication Approved: May 13, 2009 UCB's Cimzia (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis |
| May 14 | Prevacid (lansoprazole)
New Dosage Form Approved: May 13, 2009 Novartis Receives Approval From FDA To Market Prevacid 24HR As First And Only OTC Proton Pump Inhibitor In Original Prescription Formulation |
| May 18 | Risperdal (risperidone)
New Indication Approved: May 15, 2009 FDA Grants Approval for Use of Risperdal Consta as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder |
| May 19 | Samsca (tolvaptan) Tablets Date of Approval: May 19, 2009 Company: Otsuka Pharmaceutical Development & Commercialization, Inc. Treatment for: Hyponatremia Samsca (tolvaptan) is an oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia. FDA Approves Samsca (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia |
| May 22 | Adcirca (tadalafil) Tablets Date of Approval: May 22, 2009 Company: United Therapeutics Corporation Treatment for: Pulmonary Hypertension Adcirca (tadalafil) is a once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). FDA Approves Adcirca (tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension |
| 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 |
| May 28 | Prograf (tacrolimus)
Labeling Revision Approved: May 19, 2009 Astellas Receives FDA Approval for Use of Prograf (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients |
| May 28 | Besivance (besifloxacin) Ophthalmic Suspension Date of Approval: May 28, 2009 Company: Bausch & Lomb Treatment for: Bacterial Conjunctivitis Besivance (besifloxacin ophthalmic suspension) is a topical quinolone antimicrobial for the treatment of bacterial conjunctivitis, commonly referred to as "pink eye." Bausch & Lomb Receives FDA Approval of Besivance, New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye') |
New Drug Approvals Archive
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