New Drug Approvals Archive - February 2010

Oleptro (trazodone) Extended Release Tablets

Date of Approval: February 2, 2010
Company: Labopharm Inc.
Treatment for: Depression

Marketing Status: Discontinued

Oleptro (trazodone) is a once-daily serotonin antagonist reuptake inhibitor (SARI) formulation for the treatment of major depressive disorder (MDD) in adults.

• Labopharm Receives FDA Approval for Oleptro
• Oleptro (trazodone) FDA Approval History

Xiaflex (collagenase clostridium histolyticum)

Date of Approval: February 3, 2010
Company: BioSpecifics Technologies Corp.
Treatment for: Dupuytren's Contracture

Xiaflex (collagenase clostridium histolyticum) is a collagenase product for the treatment of Dupuytren's contracture, a condition that affects the connective tissue that lies beneath the skin in the palm.

• Auxilium Announces U.S. Food and Drug Administration Approval for Xiaflex for the Treatment of Dupuytren's Contracture
• Xiaflex (collagenase clostridium histolyticum) FDA Approval History

Menveo (meningococcal conjugate vaccine)

Date of Approval: February 19, 2010
Company: Novartis Vaccines and Diagnostics
Treatment for: Meningococcal Meningitis Prophylaxis

Menveo (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.

• Novartis Gets US Approval for Menveo Meningitis Vaccine
• Menveo (meningococcal conjugate vaccine) FDA Approval History

Cayston (aztreonam lysine) Inhalation Solution

Date of Approval: February 22, 2010
Company: Gilead Sciences, Inc.
Treatment for: Pneumonia with Cystic Fibrosis

Cayston (aztreonam lysine for inhalation) is an inhaled anti-pseudomonal therapy for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa infection.

• U.S. Food and Drug Administration Approves Cayston (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
• Cayston (aztreonam lysine) FDA Approval History

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Date of Approval: February 24, 2010
Company: Pfizer Inc.
Treatment for: Pneumococcal Disease Prophylaxis

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) is a vaccine indicated for active immunization against invasive pneumococcal disease.

• FDA Approves Prevnar 13 Pneumococcal Disease Vaccine
• Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

VPRIV (velaglucerase alfa) for Injection

Date of Approval: February 26, 2010
Company: Shire plc
Treatment for: Gaucher Disease

VPRIV (velaglucerase alfa) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy for pediatric and adult patients with Type 1 Gaucher disease.

• FDA Approves VPRIV to Treat Gaucher Disease
• VPRIV (velaglucerase alfa) FDA Approval History