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).
Genmed Holding Corp. is announcing its entry into the European generic drug market with the receipt of its first marketing and distribution license for paracetamol. Also known as acetaminophen, paracetamol is an over-the-counter drug used to treat mild to moderate pain from headaches, backaches, osteoarthritis, and to reduce fever.
Abbott and Bristol-Myers Squibb Company today announced interim results from the Phase 2 portion of a Phase 1b/2 open-label study which showed a high objective response rate (ORR) among patients with relapsed multiple myeloma who received elotuzumab plus lenalidomide and low-dose dexamethasone.
Cumberland Pharmaceuticals Inc. today announced the publication of a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, compared to liquid lactulose products.
New research shows that anti-microbial medications are a common cause of drug-induced liver injury (DILI) leading to acute liver failure (ALF), with women and minorities disproportionately affected.
Zogenix, Inc. today announced completion of enrollment in its open-label Phase 3 safety study (Study 802) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.
A study that appears in the current issue of Psychotherapy and Psychosomatics addresses the association between use of aspirin and statins and the risk of major depression.
Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne's decision and requested that they voluntarily remove their products as well.
Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. With today's verdict, Merck has won three of the first four bellwether cases in the FOSAMAX litigation.
NeurogesX, Inc. a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced that the Centers for Medicare and Medicaid Services (CMS) has granted a unique, Level II Health Care Common Procedural Coding System (Level II HCPCS), commonly referred to as a J-code, for Qutenza (capsaicin) 8% patch.
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 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.