New Drug Approvals Archive

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January 2011

January 3

Intelence (etravirine)

New Formulation Approved: December 22, 2010

Intelence (etravirine) FDA Approval History

January 5

Actemra (tocilizumab)

Labeling Revision Approved: January 4, 2011

Actemra (tocilizumab) FDA Approval History

January 7

Abstral (fentanyl) Sublingual Tablets

Date of Approval: January 7, 2011
Company: Orexo AB
Treatment for: Pain

Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients.

Abstral (fentanyl) FDA Approval History

January 14

DaTscan (ioflupane I 123) Injection

Date of Approval: January 14, 2011
Company: GE Healthcare
Treatment for: Diagnostic

DaTscan (ioflupane I 123 injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).

DaTscan (ioflupane I 123) FDA Approval History

January 18

Natroba (spinosad) Topical Suspension

Date of Approval: January 18, 2011
Company: ParaPRO LLC
Treatment for: Lice

Natroba (spinosad) is a pediculicide indicated for the topical treatment of head lice infestations.

Natroba (spinosad) FDA Approval History

January 21

Viibryd (vilazodone) Tablets

Date of Approval: January 21, 2011
Company: Trovis Pharmaceuticals LLC
Treatment for: Depression

Viibryd (vilazodone) is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist indicated for the treatment of major depressive disorder (MDD).

Viibryd (vilazodone) FDA Approval History

January 31

Rituxan (rituximab)

New Indication Approved: January 28, 2011

January 28

Gralise (gabapentin) Extended Release Tablets - formerly DM-1796

Date of Approval: January 28, 2011
Company: Depomed, Inc.
Treatment for: Postherpetic Neuralgia

Gralise (gabapentin) is an extended release, tablet formulation of the approved antiepileptic agent gabapentin, indicated for the once-daily treatment of post-herpetic neuralgia (PHN).

Gralise (gabapentin) FDA Approval History

January 31

Menveo (meningococcal conjugate vaccine)

Patient Population Altered: January 28, 2011

Menveo (meningococcal conjugate vaccine) FDA Approval History

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