New Drug Approvals Archive - January 2011

Abstral (fentanyl) Sublingual Tablets

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

Marketing Status: Discontinued

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

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