Topiramate 25mg, 50mg, 100mg, 200mg; tabs.
Topiramate 15mg, 25mg; coated beads in caps.
Alendronate (as sodium) 70mg; tabs.
Alendronate (as sodium), cholecalciferol (Vit. D3); 70mg/2800 IU, 70mg/5600 IU; tabs.
The FDA has approved Topamax (topiramate; Janssen) for migraine prophylaxis in adolescents aged 12-17 years old. This is the first drug approval for a migraine prophylactic in this age group.
Ortho-McNeil Neurologics has announced that it is changing the appearance of Topamax (topiramate) Tablets to help reduce medication errors involving Toprol XL (metoprolol succinate extended-release tablets, from AstraZeneca).
Ortho-McNeil Neurologics announced a voluntary recall of two lots of Topamax (topiramate) 100mg tablets, 60-count bottles, because of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).
Drugs in the Pipeline
The FDA has granted Captisol-enabled Topiramate Injection (Ligand Pharmaceuticals) Orphan Drug Designation for the treatment of partial onset or primary generalized tonic-clonic seizures in hospitalized epilepsy patients who are unable to take oral topiramate.
Drug Monograph Updates
The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of May. The chart below provides highlights of key monograph updates made this month (not an inclusive list).
The FDA notified healthcare professionals and patients that topiramate (Topamax; Ortho-McNeil) is now being placed in Pregnancy Category D after new human data showed an increased risk of development of cleft lip and/or cleft palate in infants born to women treated with topiramate during pregnancy.