The pain-reliever acetaminophen (also known as paracetomol) is one of the best-selling over-the-counter medications, used by more than 200 million Americans a year. It is sold under many brand names, including Tylenol, and is an ingredient in nearly 200 medications, both over-the-counter (such as Excedrin, Midol, NyQuil, and Sudafed) and prescription (such as Vicodin).
Cara Therapeutics, Inc. today announced positive data in a Phase II proof-of-concept clinical trial of its peripherally-restricted kappa opioid agonist, CR845. The 46 patient Phase II, multi-center, double-blind, placebo-controlled study was conducted at eight hospitals in the United States and evaluated the efficacy and safety of CR845 in women following laparoscopic-assisted hysterectomy.
Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. Amneal’s generic is an AB-rated, therapeutically equivalent alternative to Ultracet® (a licensed trademark of Ortho-McNeil Janssen). U.S. sales of Tramadol/APAP were $61 MM according to June 2009 IMS Health market data.
Children who were exposed to acetaminophen prenatally were more likely to have asthma symptoms at age five in a study of 300 African-American and Dominican Republic children living in New York City.
Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications.
Depomed, Inc. announced today that it has received a second $500,000 milestone payment under its worldwide license agreement with Covidien focusing on the exclusive development of four acetaminophen/opioid analgesic combination products utilizing Depomed’s Acuform® gastric retentive drug delivery technology. The most recent payment from Covidien, which was received in December 2009, relates to the development of a formulation for the second product candidate under the collaboration.
Nearly two-thirds of the children with Autistic Spectrum Disorders recorded in the National Birth Defect Registry (NBDR) also suffer from structural birth defects, according the national nonprofit, Birth Defect Research for Children (BDRC).
The pain reliever acetaminophen is one of the safest and most effective drugs on the market. It's often recommended instead of aspirin as a day-to-day pain reliever because it's much easier on the stomach than other over-the-counter options and is considered safe when taken properly.
Labopharm Inc. today announced it has settled the previously announced draw down of $1 million under its standby equity distribution (SEDA) with YA Global Master SPV Ltd. (YA). Under the draw down, Labopharm issued 482,165 of its common shares to YA at a price of $2.07 per common share, net of the applicable discount. (All currency figures are in Canadian dollars.)
An article by Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, titled "A Difficult Balance - Pain Management, Drug Safety, and the FDA," appears in the Nov. 26, 2009 issue of The New England Journal of Medicine.
Labopharm Inc. today announced it has provided YA Global Master SPV Ltd. with notice of its intention to draw down $1 million under its previously announced standby equity distribution agreement (SEDA). (All currency figures are in Canadian dollars.)
Labopharm Inc. today announced its wholly owned subsidiary, Labopharm Europe Limited, has completed a distribution and supply agreement with Merck Sharp & Dohme Limited (MSD), a United Kingdom (U.K.) subsidiary of Merck & Co., Inc., under which MSD will distribute and market Tradorec XL(R) (once-daily tramadol based on Labopharm's proprietary Contramid(R) technology).
Fitch Ratings has affirmed Covidien plc's (Covidien) ratings.
The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using the recalled products immediately unless otherwise instructed.
In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is expanding its voluntary recall to include all available product lots of TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided below).
Labopharm Inc. today announced it has initiated the regulatory approval process for its twice-daily tramadol-acetaminophen formulation in Europe under the Decentralized Procedure (DCP). The DCP provides an efficient mechanism that allows a company to simultaneously pursue regulatory approval for a medicinal product in multiple jurisdictions in Europe.
Cumberland Pharmaceuticals Inc. (CPIX) today announced new top-line results for a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, compared to similar products in liquid forms.
Patheon a global provider of drug development and manufacturing services to the international pharmaceutical industry announced today that it has successfully released the first commercial shipments of SUMAVEL DosePro (sumatriptan injection) to Zogenix in anticipation of the planned U.S. commercial product launch scheduled in January 2010.
"Eating food is an important element in reducing drinking and reducing risk of intoxication," Garbutt said. Eat a meal before you take your first sip of alcohol, he advises, and continue to take in food as the night wears on. Food, fats especially, help slow down the body's absorption of alcohol. But to truly be effective, the food must be in your stomach first. If you wait until you're feeling buzzed or tipsy to start eating, it's already too late.
Zogenix, Inc., a privately held pharmaceutical company, announced today that it has closed a $35 million second tranche of a Series B preferred stock financing. The Series B round was increased from $51 million, previously announced in September, to $71 million. The additional $20 million investment was made by Chicago Growth Partners, which will now be represented on the Zogenix Board of Directors by Dr. Arda Minocherhomjee.
Cumberland Pharmaceuticals Inc. announced today that data from a recent clinical trial for Caldolor® (ibuprofen) Injection, an intravenous treatment for pain and fever, will be presented at the 44th American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting in Las Vegas, Nevada, in December.
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