The FDA has issued a non-approvable letter to Forest Laboratories in response to its supplemental New Drug Application (sNDA) to expand the indication of memantine HCl (Namenda®) to include the treatment of mild Alzheimer’s disease (AD). Memantine was approved for the treatment of moderate-to-severe AD in October 2003. After the FDA accepted the sNDA for [...]
For the first time, scientists have found that a placebo with implied pain-relieving properties directly activates the brain’s chemistry involved in regulating and suppressing pain. The therapeutic benefits were noted after the subjects received an inert substance that was suggested to reduce pain. Implied pain-relieving placebos have also been associated with reductions in the subjects’ [...]
Patients with the metabolic syndrome have a high risk of myocardial infarction (MI). Could bezafibrate (e.g., Bezalip®, Roche), a derivative of fibric acid, be helpful? Researchers from Israel studied 1,470 patients with at least three risk factors for the syndrome: a fasting glucose level of 110 mg/dl; a triglyceride level of 150 mg/dl; a high-density [...]
Although the combination treatments of salmeterol/fluticasone propionate (e.g., Generic Advair® Diskus, GlaxoSmithKline) and ipratropium/albuterol medication (Combivent drug, Boehringer Ingelheim) have been widely used to treat chronic obstructive pulmonary disease (COPD), only one published study has compared these agents head to head. Investigators from National Jewish Medical and Research Center in Denver, Baylor College of Medicine [...]
The FDA has approved Fluarix™ (GlaxoSmithKline), an influenza vaccine for adults 18 years of age and older against influenza virus types A and B. The first vaccine to be approved via the FDA’s accelerated approval process, Fluarix™ contains inactivated virus. The FDA evaluated the vaccine’s safety and effectiveness after four clinical studies involving approximately 1,200 [...]
Barr Laboratories, Inc., has received the FDA’s approval for its ANDA to manufacture leflunomide tablets, 10 and 20 mg, the generic equivalent of Arava Tablets (Aventis). Leflunomide is indicated for adults with active rheumatoid arthritis.
A combined hormonal therapy of drospirenone drug and estradiol tablet (Angeliq®, Berlex, a Schering affiliate) has been approved to treat vasomotor symptoms, such as hot flashes and night sweats, in menopausal women. This is the only hormonal therapy containing the unique progestin drospirenone.
