New Drug Approvals Archive - January 2011
New Formulation Approved: December 22, 2010
Labeling Revision Approved: January 4, 2011
Abstral (fentanyl) Sublingual Tablets
Date of Approval: January 7, 2011
Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients.
DaTscan (ioflupane I 123) Injection
Date of Approval: January 14, 2011
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).
Natroba (spinosad) Topical Suspension
Date of Approval: January 18, 2011
Natroba (spinosad) is a pediculicide indicated for the topical treatment of head lice infestations.
Viibryd (vilazodone) Tablets
Date of Approval: January 21, 2011
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).
New Indication Approved: January 28, 2011
Gralise (gabapentin) Extended Release Tablets - formerly DM-1796
Date of Approval: January 28, 2011
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).
Menveo (meningococcal conjugate vaccine)
Patient Population Altered: January 28, 2011
New Dosage Regimen: March 16, 2015