The U.S. Food and Drug Administration approved once-daily VeramystTM fluticasone furoate Nasal Spray on Friday to treat seasonal and year-round allergy symptoms in adults and children two years of age and older. Veramyst will be available by prescription nationwide by late May 2007.
By Naomi Aoki, The Boston Globe Knight Ridder/Tribune Business News May 16--In the campaign to make the nation's top-selling allergy drugs available without a prescription, Marlborough-based Sepracor Inc. may be the only drug company with a stake in the popular antihistamines to emerge unscathed....
WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration FDA has approved SINGULAIRR montelukast sodium for the relief of symptoms of perennial allergic rhinitis PAR, or indoor allergies, in adults and children six months of age and older. A convenient once-a-day tablet,...
Byline: Paul Winston No doubt someone is sneezing as they read this. Someone is probably trying to see the words on this page through eyes that are watery, itchy and bloodshot, while someone else may be sitting immobile, hoping that the twitchy se ...
STOCKHOLM, Sweden -- Regulatory News: MEDA AB (STO:MEDAA): The New Drug Application NDA for a newly formulated higher strength azelastine nasal spray has now been accepted by the Food and Drug Administration FDA as complete for substantive review after initial evaluation. "This product has...
Randomized, double-blind, placebo-controlled study conducted in the U.S. demonstrated both the efficacy and safety of Nasacort AQR in children with nasal symptoms associated with perennial allergic rhinitis BRIDGEWATER, N.J., Sept. 23 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today the U.S. Food and Drug Administration FDA has approved Nasacort AQ...
WASHINGTON -- At the invitation of the U.S. Food and Drug Administration FDA, Scott Mandell, CEO, President and Co-Founder of Enjoy Life Foods, the country's leading manufacturer of allergy-friendly and gluten-free foods, provided comments at a public meeting on the use of advisory labeling of allergens in foods. Mandell cautioned...
Responding to concerns that food labels aren't doing enough to alert consumers to the presence of allergens, or that the labels are just plain confusing, the U.S. Food and Drug Administration is hosting a public hearing Tuesday on what it can do to improve things. "If you go down the...
Food Allergy Awareness Week, May 11-17, 2008 SCHILLER PARK, Ill. -- A single, innocent parent oversight resulting in a child's anaphylactic reaction to one of its allergy-friendly foods recently prompted one company to voluntarily strengthen the food allergy labeling on all of its products. "As the...
The Food and Drug Administration has issued an "early communication" to health care professionals regarding its review of the postmarketing reports it has received of behavior/mood changes, suicidality, and suicide in patients who have taken the asthma and allergy medication montelukast Singulair. At press time, the agency had...
M2 PRESSWIRE-4 April 2008-MarketResearch.com: "The Return of the Rx to OTC Switch: Market Analysis and Product Management Strategies" by Kalorama Information April 2008C1994-2008 M2 COMMUNICATIONS LTD RDATE:04042008 Lagging FDA approvals led to a brief absence of Rx to OTC...
WASHINGTON -- The Food and Drug Administration said Thursday it is investigating a possible link between Merck's best-selling Singulair and suicide. The FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy...
WASHINGTON -- The Food and Drug Administration said Thursday it is investigating a possible link between Merck's best-selling Singulair and suicide. The FDA said it is reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who have taken the popular allergy...
The Food and Drug Administration is investigating anecdotal reports that people who use Singulair, the popular asthma and allergy drug, are at greater risk for suicidal thoughts and suicide. Singulair is a pill prescribed to treat asthma and hay fever symptoms such as sneezing and a nose that...
ALLEGAN, Mich. -- Perrigo Co. and its supply partner Teva Pharmaceuticals Industries Ltd. announced earlier this month that they had received final Food and Drug Administration approval to market a store brand version of McNeil Consumer Healthcare's over-the-counter Zyrtec-D extended-release allergy medication. Just two days earlier Perrigo began...
TIP UPDATE: Share price in the doldrums as stand-off with FDA shows no sign of easing. Richard Hemming Allergy Therapeutics' shares fell over 15 per cent after management said it had no idea when the US regulator's suspension of clinical trials for its...
The FDA has approved Xyzal, an oral solution for relieving seasonal and year-round allergies. The product is being marketed by UCB and sanofi-aventis...
Brussels, Belgium and Paris, France - February 19, 2008 at 8:00 amCET - UCB and sanofi-aventis announced today that the U.S. Food andDrug Administration FDA approved a New Drug Application NDA forXYZAL® levocetirizine dihydrochloride0.5 mg/mL oral solution, a prescription antihistamine indicated forthe relief of symptoms associated with indoor and outdoor...
William Maier, M.D., Eugene, OR, received a 483 with three citations because he failed to maintain accurate case histories. Also, the researcher did not report to the sponsor adverse events AEs that may have been caused by the investigational drug, FDA records show. Investigator Astrida Mattson from the...
Articles 2008-02-12
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