New Drug Approvals Archive - June 2013
New Indication Approved: June 5, 2013
- FDA Approves Revlimid (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma
Read more: Revlimid (lenalidomide) FDA Approval History
Fluzone (influenza virus vaccine, inactivated)
New Formulation Approved: June 10, 2013
New Indication Approved: June 13, 2013
Read more: 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
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
Read more: Sprycel (dasatinib) FDA Approval History
New Indication Approved: June 21, 2013
Read more: Vibativ (telavancin) FDA Approval History
Mycamine (micafungin sodium)
Patient Population Altered: June 21, 2013
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
New Indication Approved: June 27, 2013
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.