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