New Drug Approvals Archive - February 2010

Tykerb (lapatinib ditosylate)

New Indication Approved: January 29, 2010

• GSK's Tykerb Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer
• Tykerb (lapatinib ditosylate) FDA Approval History

Oleptro (trazodone) Extended Release Tablets - formerly DDS-04A

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

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

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

Crestor (rosuvastatin calcium)

New Indication Approved: February 8, 2010

• FDA Approves Crestor to Reduce Stroke, Heart Attack Risk

Benicar (olmesartan medoxomil)

Patient Population Altered: February 4, 2010

• FDA Approves Benicar for the Treatment of High Blood Pressure in Children and Adolescents aged 6-16

Norvir (ritonavir)

New Formulation Approved: February 10, 2010

• Abbott Receives U.S. FDA Approval for Heat-Stable Norvir (ritonavir) Tablets

Rituxan (rituximab)

New Indication Approved: February 18, 2010

• FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia

Mirapex (pramipexole dihydrochloride)

New Dosage Form Approved: February 19, 2010

• FDA Approves Once-Daily Mirapex ER for the Treatment of Early Parkinson's Disease

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

Menveo (meningococcal conjugate vaccine)

Patient Population Altered: January 28, 2011

• FDA Approves the Novartis Quadrivalent Meningococcal Conjugate Vaccine, Menveo, for Use in Children From 2 Years of Age
• Menveo (meningococcal conjugate vaccine) FDA Approval History

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: December 30, 2011

• FDA Expands Use of Prevnar 13 Vaccine for People Ages 50 and Older
• Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: January 25, 2013

• Pfizer Receives FDA Approval For The Use Of Prevnar 13 In Vaccine-Naive Children And Adolescents Aged 6 Years Through 17 Years For The Prevention Of Invasive Pneumococcal Disease
• Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

Menveo (meningococcal conjugate vaccine)

Patient Population Altered: August 2, 2013

• FDA Expands Age Indication for Menveo
• Menveo (meningococcal conjugate vaccine) FDA Approval History

Xiaflex (collagenase clostridium histolyticum)

New Indication Approved: December 6, 2013
Treatment for: Dupuytren's Contracture

• FDA Approves Xiaflex as First Drug Treatment for Peyronie’s Disease
• Xiaflex (collagenase clostridium histolyticum) FDA Approval History

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: July 11, 2016

• Pfizer Receives FDA Approval for Prevnar 13 in Adults Age 18 Through 49
• Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History