New Drug Approvals Archive

Get news by email or subscribe to our news feeds.

February 2010

February 1

Tykerb (lapatinib ditosylate)

New Indication Approved: January 29, 2010

Tykerb (lapatinib ditosylate) FDA Approval History

February 2

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.

Oleptro (trazodone) FDA Approval History

February 3

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.

Xiaflex (collagenase clostridium histolyticum) FDA Approval History

February 5

Lamictal XR (lamotrigine)

New Indication Approved: January 29, 2010

Lamictal XR (lamotrigine) FDA Approval History

February 9

Crestor (rosuvastatin calcium)

New Indication Approved: February 8, 2010

February 11

Benicar (olmesartan medoxomil)

Patient Population Altered: February 4, 2010

February 12

Norvir (ritonavir)

New Formulation Approved: February 10, 2010

February 19

Rituxan (rituximab)

New Indication Approved: February 18, 2010

February 22

Mirapex (pramipexole dihydrochloride)

New Dosage Form Approved: February 19, 2010

February 19

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.

Menveo (meningococcal conjugate vaccine) FDA Approval History

February 22

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.

Cayston (aztreonam lysine) FDA Approval History

February 24

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

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

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) is a vaccine indicated for active immunization against invasive pneumococcal disease in infants, young children and adults ages 50 and older.

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

February 26

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.

VPRIV (velaglucerase alfa) FDA Approval History

January 31

Menveo (meningococcal conjugate vaccine)

Patient Population Altered: January 28, 2011

Menveo (meningococcal conjugate vaccine) FDA Approval History

January 3

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: December 30, 2011

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

January 25

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)

Patient Population Altered: January 25, 2013

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) FDA Approval History

August 2

Menveo (meningococcal conjugate vaccine)

Patient Population Altered: August 2, 2013

Menveo (meningococcal conjugate vaccine) FDA Approval History

December 6

Xiaflex (collagenase clostridium histolyticum)

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

Xiaflex (collagenase clostridium histolyticum) FDA Approval History

Hide
(web2)