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).
Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its civamide (zucapsaicin) 0.075% cream, CIVANEX®, for the treatment of signs and symptoms of osteoarthritis of the knee.
Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration (FDA) approved Butrans™ (buprenorphine) Transdermal System CIII for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Butrans Transdermal System is an analgesic product that delivers continuous release of medication for seven days.
Reporting in the journal Urology, researchers at Thomas Jefferson University have found that a pre-emptive multimodal pain regimen that included pregabalin (Lyrica) decreased the use of opioid analgesics in patients undergoing robotic-assisted laparoscopic radical prostatectomy.
Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.
Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.
Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, announced today that it has signed an agreement providing Cadence with an exclusive option to acquire Incline Therapeutics, Inc., a privately held specialty pharmaceutical company.
DURECT Corporation announced today results from a European Phase IIb hysterectomy clinical trial conducted by Nycomed of POSIDUR™ (also known as SABER™-bupivacaine or Optesia™ in the E.U.), a proprietary product under development for the treatment of post-surgical pain.
Bayer's CONTOUR® USB meter, the first blood glucose monitor with unique plug & play diabetes management software, today received a silver Medical Design Excellence Award (MDEA). The MDEA recognizes excellence in medical product design and manufacturing. The independent judges for the prestigious award, sponsored by the specialist journal Medical Device and Diagnostic Industry, acknowledged the great innovative power and particularly user-friendly operation of Bayer's CONTOUR USB meter.
Labopharm Inc. today commented on the outcome of the appeal by Purdue Pharma Products L.P. and the cross-appeal by Par Pharmaceutical Companies, Inc. of the decision of the United States District Court for the District of Delaware in August 2009 on patent-infringement litigation initiated by Purdue against Par relating to Ultram ER (tramadol hydrochloride extended-release tablets).
In the May issue of Mayo Clinic Proceedings, physician experts review current practices for pain management in cirrhotic patients. The physician experts reviewed all current literature available on PubMed and MEDLINE with no limits in the search to recommend a uniform and practical guide to approaching analgesia in the cirrhotic patients.
Abbott today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new FreeStyle Lite blood glucose test strips. The new FreeStyle Lite test strips minimize interference during blood glucose testing and are designed to offer a better testing experience.
Labopharm Inc. today announced that it has completed the previously announced transaction to establish a joint venture with Gruppo Angelini.
Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified the OFIRMEV™ (acetaminophen) injection New Drug Application (NDA) resubmission as a complete Class 2 response to the FDA's February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.
Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote® (acetylcysteine) Injection has been granted regulatory approval for marketing and sale in Australia. Acetadote, an injectable drug used to treat acetaminophen (paracetamol) overdose, was approved by the Therapeutic Goods Administration (TGA), the government agency responsible for regulating drugs and medical devices in Australia.
Scientists at the University of Pittsburgh School of Medicine went on a molecular fishing trip and netted a catch of new mediators that not only can explain how omega-3 fatty acids reduce inflammation, but also hint at novel treatments for a host of diseases linked to inflammatory processes. Their findings were published today in the online version of Nature Chemical Biology.
Labopharm Inc. today reported its financial results for the first quarter 2010.
Cadence Pharmaceuticals, Inc. announced today that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational product candidate, OFIRMEV™ (acetaminophen) injection, for the treatment of pain and fever in adults and children.
Despite their widespread use by parents and caregivers, over-the-counter (OTC) cold and cough medicines have carried a warning by the FDA since 2008, and still have the potential to cause serious adverse events in infants and children. Conservative therapies, including nasal suctioning, humidification, and nasal saline, should be recommended over routine use of OTC cough/cold products in infants and children, according to a new commentary published in the May 2010 issue of Otolaryngology - Head and Neck Surgery.
Despite their widespread use by parents and caregivers, over-the-counter cold and cough medicines have carried a warning by the FDA since 2008, and still have the potential to cause serious adverse events in infants and children. Conservative therapies, including nasal suctioning, humidification, and nasal saline, should be recommended over routine use of OTC cough/cold products in infants and children, according to a new commentary published in the May 2010 issue of Otolaryngology - Head and Neck Surgery.
The majority of teens say they have never heard of acetaminophen - or what the appropriate dosing of it is even with access to the label instructions - despite having taken the medication recently, according to a new University of Rochester Medical Center Study assessing teens' health literacy. More than 60 percent of the teens in the study had never before heard of acetaminophen despite 21 percent of them having taken it within the previous month.
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