Latest Enantiopure drugs Stories
OSAKA, Japan, Aug. 22 /PRNewswire-FirstCall/ -- Hospira Japan Co., Ltd. today announced it has received an approval for the long-term (greater than 24 hour) use of the sedative "Precedex IV(TM)200ug" (generic name: dexmedetomidine hydrochloride). This approval follows Hospira's first launches earlier this year of Precedex in Canada and in South Korea, important milestones for Hospira as the company continues to build the molecule's global presence. Originally, Precedex was approved in...
FORT LEE, N.J., March 10 /PRNewswire/ -- Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), today announced that the U.S. Food and Drug Administration (FDA) recently accepted for review the lurasidone New Drug Application (NDA) for the treatment of patients with acute schizophrenia. The NDA was submitted to FDA on December 30, 2009 and will receive a standard review. "We are pleased that the lurasidone NDA has been accepted for...
Although the increasing use of smart drugs known as "nootropics" will be hard to ban, it could lead to the use of routine doping tests for exam students, according to a report issued Wednesday.Writing in the Journal of Medical Ethics, Vince Cakic of the Department of Psychology at the University of Sydney pointed to the abuse of smart drugs among students wanting to achieve higher academic standing.Cakic compares the situation to the controversial use of performance drugs in professional...
ATLANTA, April 10 /PRNewswire/ -- Once-daily Keppra XR(TM) (levetiracetam) extended-release tablets are now available in a new dosage strength--750 mg--enabling doctors to simplify patients' treatment plans by decreasing the number of tablets they take each day. (Photo: http://www.newscom.com/cgi-bin/prnh/20090410/NY97244 ) According to studies published in Epilepsy & Behavior and Neurology, patients are more likely to adhere to their medication regimen when it is taken once daily,...
U.S. authorities accused a New York pharmaceutical company Wednesday of making false claims about two antidepressants it markets for unapproved pediatric use. The civil complaint unsealed in U.S. District Court in Massachusetts, not only alleges Forest Laboratories Inc. marketed Celexa and Lexapro improperly but that it paid kickbacks to doctors to prescribe them. The U.S. attorney's office alleges the company's illegal promotional tactics caused thousands of false and fraudulent claims to...
Pharmaceutical Company Allegedly Marketed Drugs for Unapproved Pediatric Use and Paid Kickbacks WASHINGTON, Feb. 25 /PRNewswire-USNewswire/ -- A Complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company's marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs. Acting Assistant Attorney...
Studies Presented at American Epilepsy Society Annual Meeting ATLANTA, Dec. 9 /PRNewswire-FirstCall/ -- UCB today announced findings from new studies of the once-daily antiepileptic drug (AED) Keppra XR(TM) (levetiracetam) extended-release tablets comparing tolerability versus levetiracetam immediate release (IR) and reporting on additional dosing schedules. The data were among five studies that were presented at the 62nd annual meeting of the American Epilepsy Society (AES) in Seattle....
Mylan, a generic pharmaceutical company, has announced that its subsidiary Mylan Pharmaceuticals received final approval from the FDA for its abbreviated new drug application for levetiracetam tablets, 250mg, 500mg and 750mg. Levetiracetam tablets are the generic version of UCB Pharma's Keppra. Mylan and UCB Societe Anonyme and UCB Pharma have previously entered into an agreement to settle pending litigation relating to levetiracetam tablets. Pursuant to the settlement, Mylan was given the...
US-based pharmaceutical company Sepracor has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending to grant a marketing authorization for Lunivia brand eszopiclone in the EU for the treatment of insomnia. The EU labeling provides for patients who require longer-term therapy to be treated for up to six months, with the usual course of therapy for typical patients being short term. Lunivia is marketed in the US...
Sepracor Inc. (Nasdaq: SEPR) today announced that the EMEA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending to grant a marketing authorization for LUNIVIA(R) brand eszopiclone in the European Union (EU) for the treatment of insomnia. The EU labeling provides for patients who require longer-term therapy to be treated for up to six months, with the usual course of therapy for typical patients being short-term. LUNIVIA is marketed in the U.S....
