New Drug Approvals Archive

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June 2013

June 5

Revlimid (lenalidomide)

New Indication Approved: June 5, 2013

Revlimid (lenalidomide) FDA Approval History

June 11

Fluzone (influenza virus vaccine, inactivated)

New Formulation Approved: June 10, 2013

June 13

Xgeva (denosumab)

New Indication Approved: June 13, 2013

Xgeva (denosumab) FDA Approval History

June 20

Plan B One-Step (levonorgestrel)

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

Plan B One-Step (levonorgestrel) FDA Approval History

June 21

Sprycel (dasatinib)

Labeling Revision Approved: June 17, 2013

Sprycel (dasatinib) FDA Approval History

June 21

Vibativ (telavancin)

New Indication Approved: June 21, 2013
Treatment for: Complicated Skin and Skin Structure Infections (cSSSI), Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

Vibativ (telavancin) FDA Approval History

June 24

Mycamine (micafungin sodium)

Patient Population Altered: June 21, 2013

Mycamine (micafungin sodium) FDA Approval History

June 26

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.

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

June 28

Exelon (rivastigmine)

New Indication Approved: June 27, 2013

June 28

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.

Brisdelle (paroxetine mesylate) FDA Approval History

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