American Pharmaceutical Partners has received two tentative approvals from the FDA for its Abbreviated New Drug Applications (ANDAs) for Generic Ondansetron Injection, USP, in single-dose and multiple-dose vials. As the generic equivalent of GlaxoSmithKline’s Zofran drug Injection, it is indicated for the prevention of postoperative and chemotherapy-related nausea and vomiting.
Researchers at the University of Minnesota have found that daily doses of an experimental drug called nalmefene (Revex, BioTie Therapies, Finland), which has been used to treat alcoholism, may be able to reduce the urge to gamble.
Nalmefene, an opioid antagonist, helps to take the compulsive thrill out of winning and losing by interfering with sensations [...]
Naltrexone generic for extended-release in-jectable suspension (Vivitrol, Alkermes/ Cephalon) has been approved for the treatment of alcohol dependence.
This once-monthly injectable medication is indicated for alcohol-dependent patients who are able to abstain from drinking in an outpatient setting and who are not actively drinking when they begin treatment. This agent should be used in combination with [...]
Rivastigmine tartrate (Exelon drug, Novar-tis) has been approved for patients with mild-to-moderate dementia associated with Parkinson’s disease (PD). Rivastig-mine was previously approved for the treatment of mild-to-moderate dementia of the Alzheimer’s type.
Steven Galson, MD, MPH, Director of the FDA’s Center for Drug Evaluation and Research, explains that dementia associated with PD differs from dementia associated [...]
The FDA has approved an IV formulation of levetiracetam (Keppra tablet, UCB) solution as an infusion for the adjunctive use in the treatment of partial-onset seizures in adults with epilepsy. The 100-mg/ml injection is intended as an alternative when oral administration of levetiracetam is temporarily not feasible.
When patients are switched from the oral to the [...]
Tinidazole (Tindamax generic, Mission Phar-macal) has been approved for the treatment of bacterial vaginosis (BV), the most common vaginal infection among women of childbearing age in the U.S.
This is the first new oral therapy to be approved for the treatment of BV in a decade. It provides a shorter course of oral therapy, with fewer [...]
Novartis has received the FDA’s approval for its generic rivastigmine tartrate (Exelon drug) skin patch for patients with mild-to-moderate Alzheimer’s disease. The company said that the patch was designed with compliance in mind and was preferred to capsules by more than 70% of doctors and nurses as a method of drug delivery. The patch is [...]
