Latest Anticonvulsants Stories
WASHINGTON, May 7, 2012 /PRNewswire/ -- In what may be the largest payment ever enforced involving off-label misuse of a single drug, law firm Grant & Eisenhofer, working with the U.S. Justice Department and several state Attorneys General, has reached a $1.6 billion settlement with Abbott Laboratories over its illegal marketing of antiepileptic medication Depakote to children and geriatric patients. The settlement was reached between Abbott (NYSE: ABT) and the Justice...
ATLANTA, May 2, 2012 /PRNewswire/ -- Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, announces the approval of an Abbreviated New Drug Application (ANDA) for Gabapentin Oral Solution, 250 mg/5 mL. The Food and Drug Administration (FDA) determined that Acella's ANDA is bioequivalent - therefore, therapeutically equivalent - to the reference listed drug, Neurontin®* Oral Solution, 250 mg/5 mL. "Acella looks forward to adding Gabapentin Oral Solution to our existing...
( ) ATLANTA, April 26, 2012 /PRNewswire/ -- UCB today announced interim results from the VITOBA(TM) (VImpaT® added to One Baseline AED) study, which showed that patients with less refractory partial-onset seizures treated with Vimpat® (lacosamide) C-V as add-on to monotherapy experienced seizure reduction. These data were presented today at the 64th annual meeting of the American Academy of Neurology (AAN) in New Orleans. VITOBA(TM) is a six-month prospective, non-interventional...
MAPLE GROVE, Minn., April 26, 2012 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (http://www.upsher-smith.com) today announced that three posters characterizing the pharmacokinetic (PK) profile of USL255, its once-daily, extended-release (ER) topiramate formulation, were presented at the 64th Annual American Academy of Neurology (AAN) Meeting. One of the posters showed equivalent exposure between USL255 and equal doses of immediate-release (IR) topiramate at steady state, a...
MAPLE GROVE, Minn., April 26, 2012 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced the launch of http://www.seizureclusterstudy.com, an informational website for individuals diagnosed with partial or generalized epilepsy who experience seizure clusters and are interested in participating in an ongoing Phase III clinical trial. The study, ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray) is designed to evaluate the efficacy and safety of...
ATLANTA, April 18, 2012 /PRNewswire/ -- UCB, a leading biopharmaceutical company committed to the development of new epilepsy treatments and research, will sponsor multiple sets of key epilepsy data at the 64th Annual Meeting of the American Academy of Neurology (AAN) in New Orleans from April 21-28. The data comprise several posters examining the use of the antiepileptic drug (AED) Vimpat® (lacosamide) C-V, including updated health-related quality of life analysis from...
HUNTSVILLE, Ala., April 12, 2012 /PRNewswire-FirstCall/ -- Qualitest Pharmaceuticals today announced that the U.S. Food and Drug Administration has approved Levetiracetam Oral Solution, 100mg/mL. Qualitest plans to begin distribution in mid-2012. The total sales for Levetiracetam Oral Solution, 100mg/mL, in the U.S. for the 12 months ending Dec. 31, 2011, were approximately $62.2 million, according to IMS Health. About Qualitest Founded in 1983, Qualitest provides affordable,...
Drug manufacturer deviates from appropriate comparator therapy specified by the G-BA The drug retigabine (trade name: Trobalt®) was approved in March 2011 as add-on therapy for adults with epileptic seizures. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products” (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether retigabine offers an added benefit compared with the present standard therapy....
MAPLE GROVE, Minn., March 12, 2012 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (http://www.upsher-smith.com) today presented Phase I pharmacokinetic data evaluating the profiles of 10 internally developed once-daily, extended-release formulations of the epilepsy medication topiramate. Of the formulations investigated, one extended-release (ER) formulation of topiramate emerged as being optimal for further development by meeting all pre-established single-dose and simulated...
The makers of three previously rejected weight loss drugs have resubmitted their products to the Food and Drug Administration (FDA) for approval, with each hoping to become the first new prescription anti-obesity drug to be approved in the U.S. in 13 years. As previously reported here on RedOrbit.com, one of those three drugs, Qnexa, received approval from a panel of FDA advisors on Thursday by a 20-2 margin. That verdict placed Qnexa, a combination of the appetite suppressant...
