New Drug Approvals Archive - January 2011

Intelence (etravirine)

New Formulation Approved: December 22, 2010

• FDA Approves New Dosage Strength for Intelence

Intelence (etravirine) FDA Approval History

Actemra (tocilizumab)

Labeling Revision Approved: January 4, 2011

• FDA Grants Supplemental Approval for Actemra (tocilizumab)

Actemra (tocilizumab) FDA Approval History

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.

• FDA Approval for Abstral (Fentanyl) Sublingual Tablets

Abstral (fentanyl) FDA Approval History

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).

• FDA Approves DaTscan (Ioflupane I 123 Injection) for Visualization of Dopamine Transporters in Patients with Suspected Parkinsonian Syndromes

DaTscan (ioflupane I 123) FDA Approval History

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.

• FDA Approves Natroba Head Lice Treatment for Children and Adults

Natroba (spinosad) FDA Approval History

Viibryd (vilazodone) Tablets

Date of Approval: January 21, 2011
Company: Allergan, Inc.
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).

• FDA Approves Viibryd to Treat Major Depressive Disorder

Viibryd (vilazodone) FDA Approval History

Rituxan (rituximab)

New Indication Approved: January 28, 2011

• FDA Approves Rituxan for First-Line Maintenance Use in Follicular Lymphoma

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).

• Depomed Announces US Food and Drug Administration Approval of Gralise (gabapentin) Once-Daily Tablets for Treatment of Post-Herpetic Neuralgia

Gralise (gabapentin) FDA Approval History

Menveo (meningococcal conjugate vaccine)

Patient Population Altered: January 28, 2011

• FDA Approves the Novartis Quadrivalent Meningococcal Conjugate Vaccine, Menveo, for Use in Children From 2 Years of Age

Menveo (meningococcal conjugate vaccine) FDA Approval History

Viibryd (vilazodone)

New Dosage Regimen: March 16, 2015

• Actavis Receives FDA Approval for Viibryd (vilazodone HCl) 20mg Once Daily as a Therapeutic Dose

Viibryd (vilazodone) FDA Approval History