New Drug Approvals Archive - June 2013

Revlimid (lenalidomide)

New Indication Approved: June 5, 2013

• FDA Approves Revlimid (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma

Revlimid (lenalidomide) FDA Approval History

Fluzone (influenza virus vaccine, inactivated)

New Formulation Approved: June 10, 2013

• New Fluzone Quadrivalent Four-Strain Influenza Vaccine from Sanofi Pasteur Now Licensed By FDA for Broad Age Range of Children and Adults

Xgeva (denosumab)

New Indication Approved: June 13, 2013

• FDA Approves Xgeva to Treat Giant Cell Tumor of the Bone

Xgeva (denosumab) FDA Approval History

Plan B One-Step (levonorgestrel)

Patient Population Altered: June 20, 2013
Treatment for: Emergency Contraception

• FDA Approves Plan B One-Step Emergency Contraceptive For Use Without A Prescription For All Women Of Child-Bearing Potential

Plan B One-Step (levonorgestrel) FDA Approval History

Sprycel (dasatinib)

Labeling Revision Approved: June 17, 2013

• FDA Approves U.S. Product Labeling Update for Sprycel (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase

Sprycel (dasatinib) FDA Approval History

Vibativ (telavancin)

New Indication Approved: June 21, 2013

• FDA Approves Vibativ for Hospitalized Patients with Bacterial Pneumonia

Vibativ (telavancin) FDA Approval History

Mycamine (micafungin sodium)

Patient Population Altered: June 21, 2013

• FDA Approves Pediatric Indication for Astellas' Mycamine (micafungin sodium) for Injection

Mycamine (micafungin sodium) FDA Approval History

Rixubis (coagulation factor IX (recombinant)) Injection

Date of Approval: June 26, 2013
Company: Baxter International Inc.
Treatment for: Hemophilia B

Rixubis (coagulation factor IX, recombinant) is an antihemophilic factor indicated for the control and prevention of bleeding episodes in adults with hemophilia B.

• FDA Approves Rixubis - First Recombinant Coagulation Factor IX For Use in Preventing Bleeding Episodes

Rixubis (coagulation factor IX (recombinant)) FDA Approval History

Exelon (rivastigmine)

New Indication Approved: June 27, 2013

• Novartis Exelon Patch Now FDA Approved to Treat Patients Across all Stages of Alzheimer's Disease

Brisdelle (paroxetine mesylate) Capsules - formerly LDMP

Date of Approval: June 28, 2013
Company: Noven Pharmaceuticals, Inc.
Treatment for: Hot Flashes Associated with Menopause

Brisdelle (paroxetine mesylate) is a low-dose selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

• FDA Approves Brisdelle - First Non-Hormonal Treatment for Hot Flashes Associated with Menopause

Brisdelle (paroxetine mesylate) FDA Approval History