New Drug Approvals

New Drug Approvals

The following drugs have recently been approved by the FDA.
VPRIV (velaglucerase alfa) for Injection
Date of Approval: February 26, 2010
Treatment for: Gaucher Disease
VPRIV Drug Information | Press Release

Prevnar 13 (pneumococcal 13-valent conjugate vaccine)
Date of Approval: February 24, 2010
Treatment for: Pneumococcal Disease Prophylaxis
Prevnar 13 Drug Information | Press Release

Cayston (aztreonam lysine) Inhalation Solution
Date of Approval: February 22, 2010
Treatment for: Pneumonia with Cystic Fibrosis
Cayston Drug Information | Press Release

Menveo (meningococcal conjugate vaccine)
Date of Approval: February 19, 2010
Treatment for: Meningococcal Meningitis Prophylaxis
Menveo Drug Information | Press Release

Xiaflex (collagenase clostridium histolyticum)
Date of Approval: February 3, 2010
Treatment for: Dupuytren's Contracture
Xiaflex Drug Information | Press Release

Oleptro (trazodone) Extended Release Tablets
Date of Approval: February 2, 2010
Treatment for: Depression
Oleptro Drug Information | Press Release

New Indications and Dosage Forms
Drugs that have gained FDA approval for the treatment of additional
diseases/conditions or new dosage forms/regimens.
Mirapex (pramipexole dihydrochloride)
New Dosage Form Approved: February 19, 2010
Now Approved: Mirapex ER for Once-Daily Treatment of Early Parkinson's Disease
Mirapex Drug Information | Press Release

Norvir (ritonavir)
New Formulation Approved: February 10, 2010
Now Approved: Norvir Tablets
Norvir Drug Information | Press Release

Rituxan (rituximab) Injection for Intravenous Use
New Indication Approved: February 18, 2010
Now Approved for: Chronic Lymphocytic Leukemia
Rituxan Drug Information | Press Release

Crestor (rosuvastatin calcium) Tablets
New Indication Approved: February 8, 2010
Now Approved for: Primary Prevention of Cardiovascular Disease
Crestor Drug Information | Press Release

Benicar (olmesartan medoxomil) Tablets
Patient Population Altered: February 4, 2010
Now Approved for: Children and Adolescents
Benicar Drug Information | Press Release

First-Time Generic Approvals
First Time Generics are those drug products that have never been
approved before as generic drug products and are new generic products
to the marketplace.
Ibutilide Fumarate Injection
0.1 mg/mL
Approved: January 11, 2010 PharmaForce, Inc.; Bioniche Pharma USA
LLC.; GeneraMedix Inc.
Generic for: Corvert

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