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New Drug Approvals Archive - May 2009

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 Cetraxal (ciprofloxacin otic) FDA Approval History
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 Avastin (bevacizumab) FDA Approval History
May 5	Cycloset (bromocriptine mesylate) Tablets Date of Approval: May 5, 2009 Company: VeroScience and S2 Therapeutics, Inc. Treatment for: Diabetes Type 2 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 Cycloset (bromocriptine mesylate) FDA Approval History
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 Fanapt (iloperidone) FDA Approval History
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 Azor (amlodipine and olmesartan) FDA Approval History
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 ACTOplus met (pioglitazone and metformin) FDA Approval History
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 Cimzia (certolizumab pegol) FDA Approval History
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 Samsca (tolvaptan) FDA Approval History
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 Adcirca (tadalafil) FDA Approval History
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 Sprycel (dasatinib) FDA Approval History
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') Besivance (besifloxacin) FDA Approval History
February 5	Lamictal XR (lamotrigine) New Indication Approved: January 29, 2010 FDA Approves Once-A-Day Lamictal XR as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures Lamictal XR (lamotrigine) FDA Approval History
April 26	Lamictal XR (lamotrigine) Labeling Revision Approved: April 25, 2011 FDA Approves Lamictal XR (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients Lamictal XR (lamotrigine) FDA Approval History

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