LONDON – AstraZeneca PLC has reported a 22 per cent rise in second quarter net profit and has also revealed that a key new drug – its blood thinner Brilinta – has been given a thumbs up by an advisory committee of the U.S. Food and Drug Administration.The Anglo-Swedish drugmaker on Thursday posted net profit [...]
Jul 29, 2010 (Datamonitor via COMTEX) Abbott, a health care company, has received FDA approval for two new dosage strengths of Simcor, a cholesterol medication.The new Simcor dosage strengths combine 40mg of simvastatin, the most commonly prescribed dose of simvastatin, with either 500mg or 1,000mg of niacin extended-release. Simcor is the first treatment to combine [...]
Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration approval of two spinal cord stimulation (SCS) leads for use with its Precision Plus? Spinal Cord Stimulator System, the world’s first rechargeable SCS device for the management of chronic pain of the trunk and/or limbs. The Linear? 3-4 and Linear? 3-6 Percutaneous [...]
Merck KGaA / Regulatory Admission28.07.2010 08:00Dissemination of an Ad hoc announcement according to 15 WpHG, transmitted byDGAP – a company of EquityStory AG.The issuer is solely responsible for the content of this announcement.-Darmstadt, Germany, July 28, 2010 – Merck KGaA announced today that theU.S. Food and Drug Administration (FDA) has accepted for filing the [...]
FDA NEWS RELEASEFDA Approves Drug for Chronic Drooling in ChildrenThe U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily [...]
Jul 27, 2010 (Datamonitor via COMTEX) Daiichi Sankyo, a Japanese pharmaceutical company, has received the FDA’s approval for Tribenzor, a new three-in-one combination product taken once-daily for the treatment of hypertension in patients who are not adequately controlled on any two of the antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers and diuretics.According to [...]
New MANUKApli is part of LMP’s ManukaMed brand of advanced wound care (AWC) dressings using medical-grade Manuka honey.Irvine, California (Vocus) July 27, 2010 Links Medical Products Inc. (LMP), a leader in the manufacture and marketing of innovative, caring products for use in both acute and long-term care, announces FDA approval for the sale [...]
Jul 27, 2010 (Datamonitor via COMTEX) Perrigo Company, a developer of OTC and generic prescription pharmaceuticals, has received a final approval from the FDA to manufacture and market over-the-counter, or OTC, cetirizine cherry syrup, 1mg/ml.According to the company, shipments will begin in the company’s fiscal first quarter of 2011. Cherry joins the currently available grape [...]
SAN ANTONIO, July 27 /PRNewswire/ AirStrip Technologies, a pioneer in mobile medical software applications, today announced that it has received U.S. Food and Drug Administration (FDA) clearance to market the AirStrip Remote Patient Monitoring solution (RPM), including AirStrip RPM CRITICAL CARE and AirStrip RPM CARDIOLOGY. (Photo: FDA clearance in place, AirStrip now extends its [...]
FDA Approves First Generic Enoxaparin Sodium InjectionFri, 23 Jul 2010The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis (DVT), a potentially deadly blood clotting condition.(c) 2010 Federal Information & News Dispatch, Inc.
