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).
Labopharm Inc. today announced that on November 11, 2010 it received notice from Actavis South Atlantic LLC advising that Actavis has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 150 and 300 mg generic versions of OLEPTRO™ (trazodone hydrochloride extended-release 150 and 300 mg tablets) in the United States.
Labopharm Inc. today reported its financial results for the third quarter and first nine months ended September 30, 2010.
Evidence suggesting that the risk of childhood asthma associated with prenatal paracetamol exposure may depend on antioxidant genes in the mother has been found by a team of UK scientists. The results of their study - which strengthens the argument for a causal link between paracetamol exposure in early life and later childhood asthma - are published online (10 November) in the Journal of Allergy and Clinical Immunology.
Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for OFIRMEV™ (acetaminophen) injection, the first and only intravenous (IV) formulation of acetaminophen to be approved in the United States. OFIRMEV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced dosing of the first patient in its Phase 2 clinical study of NGX-1998, a liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN).
New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.
NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced plans to pursue a U.S. label expansion for Qutenza® (capsaicin) 8% patch to include patients with painful HIV-associated neuropathy (HIV-AN, also referred to as HIV-distal sensory polyneuropathy (HIV-DSP)).
Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders, is pleased to announce that it has acquired world-wide rights to the active agent Cidoxepin from Gideon Pharmaceuticals. Cidoxepin is the cis-isomer of the widely prescribed tricyclic compound doxepin.
Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote (acetylcysteine) Injection, an injectable product used to treat acetaminophen (paracetamol) overdose, is now commercially available in the Australian market. Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, has an exclusive license from U.S.-based Cumberland Pharmaceuticals to market and distribute the product in Australia.
Labopharm Inc. and Paladin Labs Inc. today announced they have expanded their commercial relationship through three licensing and distribution agreements under which Paladin will distribute two of Labopharm's products in certain jurisdictions.
Labopharm Inc. today announced its twice-daily tramadol-acetaminophen has received a positive opinion under the European Union Decentralized Procedure in eight countries (Czech Republic, Iceland, Ireland, Poland, Portugal, Slovakia, Slovenia and Spain). Marketing Authorization will be granted in each country subject to the approval of translations of the Summary of Product Characteristics (SPC) and other labeling documents.
Throughout October, National Breast Cancer Awareness Month, experts from Fred Hutchinson Cancer Research Center and its clinical care partner, the Seattle Cancer Care Alliance, are offering a series of weekly research-based tip sheets regarding a variety of topics related to breast cancer, including breast cancer prevention, screening and early detection, treatment, and survivorship.
Cumberland Pharmaceuticals Inc. today announced the publication of data affirming the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in critically ill and non-critically ill adults. Published in the peer-reviewed journal Critical Care, the study showed that IV ibuprofen was significantly more effective at reducing fever in hospitalized patients than placebo.
Nautilus Neurosciences, Inc., a neurology-focused specialty pharmaceutical company, and Mission Pharmacal Company, a privately-held pharmaceutical company focused on the women's health market announced today their exclusive co-promotion agreement for CAMBIA (diclofenac potassium for oral solution) to obstetrician's, gynecologists and other women's health medical professionals.
Merck & Co., Inc. today said it will appeal a decision by the U.S. District Court for the Southern District of New York that reduced the jury verdict from $8 million to $1.5 million but denied Merck's request for judgment in its favor or a new trial in the case of Boles v. Merck, a retrial of a federal FOSAMAX case.
Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.
Headaches, back pain, arthritis and other aches distract employees and cost companies more than $61 billion a year in lost productive time, according to a study published in the Journal of the American Medical Association.
The American Pain Foundation today announced the launch of PainSAFE (Pain Safety & Access For Everyone), a new educational initiative designed for people with pain and health care professionals. The mission of PainSAFE is to provide education surrounding the appropriate and safe use of pain management therapies for people affected by pain and health care professionals, thereby, helping to reduce risk and improve access to quality pain care.
Genzyme Corporation announced today that Japan's Ministry of Health, Labour and Welfare has approved Synvisc® (hylan G-F 20; 3 x 2 mL), indicated for the treatment of osteoarthritis of the knee. Reimbursement has been obtained and publicized by Japan's Central Social Insurance Medical Council.
Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek®2010, September 8-10 in Las Vegas.
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