New Drug Approvals Archive - May 2009
Cetraxal (ciprofloxacin otic) Solution
Date of Approval: May 1, 2009
Treatment for: Otitis Externa
Cetraxal (ciprofloxacin otic) is an antibiotic ear solution for the treatment of acute otitis externa.
New Indication Approved: May 5, 2009
- FDA Grants Accelerated Approval of Avastin for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy
Read more: Avastin (bevacizumab) FDA Approval History
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.
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.
Read more: Fanapt (iloperidone) FDA Approval History
New Dosage Form Approved: May 8, 2009
Azor (amlodipine and olmesartan)
New Indication Approved: May 11, 2009
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
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
New Dosage Form Approved: May 13, 2009
New Indication Approved: May 15, 2009
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
Read more: Samsca (tolvaptan) FDA Approval History
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).
Read more: Adcirca (tadalafil) FDA Approval History
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
Read more: Sprycel (dasatinib) FDA Approval History
Labeling Revision Approved: May 19, 2009
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')
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)
Labeling Revision Approved: April 25, 2011
- FDA Approves Lamictal XR (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients