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Japanese Ministry Of Health Approves Rasilez(R), A First-in-class Direct Renin Inhibitor (DRI), For The Treatment Of High Blood Pressure
Rasilez® (aliskiren), the first new type of high blood pressure medicine in more than a decade, has been approved for use in Japan. Rasilez directly inhibits renin9, an enzyme that triggers a process leading to high blood pressure and organ damage. The Ministry of Health, Labour and Welfare (MHLW) in Japan approved Rasilez for the treatment of high blood pressure alone or in combination with other high blood pressure medicines.
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Evaluating The ADHD Medication VYVANSE CII Demonstrated No Change In Pharmacokinetic Profile Of VYVANSE When Coadministered With Prilosec OTC 40 Mg
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced results of a study showing that coadministration of the ADHD medication VYVANSE® (lisdexamfetamine dimesylate) CII with the proton pump inhibitor (PPI) Prilosec OTC® 40 mg (20 mg X 2), did not alter the median time it took for maximum plasma concentration of d-amphetamine to be reached in the subjects evaluated. In the same study, coadministration of Prilosec OTC with ADDERALL XR resulted in a nearly 45 percent reduction in the median time to reach maximum plasma concentrations of amphetamine, the active medication. Other pharmacokinetic parameters (maximum plasma concentration and area under curve) of active medication were not altered for either VYVANSE or ADDERALL XR when coadministered with Prilosec OTC. This study, which is the first to evaluate the pharmacokinetics of VYVANSE and ADDERALL XR taken alone and with Prilosec OTC 40 mg, was recently presented at the International Congress on Clinical Pharmacy, co-sponsored by the American College of Clinical Pharmacy (ACCP), in Orlando, FL.
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Government Of Canada Acts To Protect Newborns And Infants From Bisphenol A In Polycarbonate Plastic Baby Bottles
The Government of Canada is moving forward with proposed regulations to prohibit the advertisement, sale and importation of polycarbonate plastic baby bottles that contain bisphenol A, otherwise known as BPA, to reduce newborn and infant exposure to this substance, announced the Honourable Leona Aglukkaq, Minister of Health.
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Eurand Successfully Completes Registration Procedure For Paracetamol ODT 250 And 500 Mg In The European Union

Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the Dutch Medicines Evaluation Board (MEB) informed the Company that the Decentralized Procedure (DCP) for registration of Paracetamol 250 and 500 mg Orodispersible Tablets (ODT) in several EU countries has been successfully completed. In addition to The Netherlands, which acted as the reference member state, the DCP involved the United Kingdom, Germany, France, Italy and Spain. Formal approval is now expected from each country by the end of 2009. Eurand is actively seeking a partner to market and distribute Paracetamol ODT in these countries. Paracetamol (also known as acetaminophen) is a widely used analgesic (pain reliever) and antipyretic (fever reducer). Paracetamol ODT is indicated for symptomatic treatment of mild-to-moderate pain and/or fever. The 500 mg dose is indicated in adults and adolescents (over 12 years old) only, and the 250 mg dose is for use in children from the age of four and adolescents only. The product may be taken with or without liquid. "We are pleased by the Dutch MEB"s decision regarding our Paracetamol ODT, and we look forward to receiving approval in the six individual countries later this year," said GearÃöid Faherty, Chairman and Chief Executive Officer. "We believe our formulation will deliver this well-recognized pain reliever in a more patient friendly manner, particularly for those patients who have difficulty swallowing." He noted that this is the second ODT formulation that Eurand has had approved this year. In May 2009, the FDA approved EUR-1048, marketed by GlaxoSmithKline as Lamictal® ODT™ (lamotrigine) Orally Disintegrating Tablets. Like Paracetamol ODT, Lamictal ODT uses Eurand"s AdvaTab® orally disintegrating tablet (ODT) and Microcaps® taste-masking technologies. Eurand


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