Purdue Pharma recently announced that a Phase 3 study of an investigational extended‐release formulation of hydrocodone bitartrate met its primary efficacy endpoint by showing that patients with chronic low back pain treated with the once‐daily analgesic agent experienced statistically significant reduction in pain compared with placebo.
Mallinckrodt Plc last week announced that the Food and Drug Administration approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), for the management of acute pain severe enough that it requires opioid treatment.
Pfizer has sued Torrent Pharmaceuticals in an effort to protect its erectile-dysfunction drug Viagra (sildenafil citrate) from generic competition, according to a Bloomberg News report published Tuesday.
Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.
In observance of National Poison Prevention Week, which is March 16 to 22, the National Safety Council has released a list of facts many people do not — but need to — know about prescription painkiller use.
Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.
Prescription and over-the-counter products are often the first remedy consumers turn to when seeking relief from such conditions as allergies and heartburn, according to IRI. In its latest report, "Best Practices for Rx-to-OTC Product Launches," the company offers some tactics to help drive success for companies looking to execute the category switch.
Aerocrine AB, a medical products company focused on improved management and care of patients with such inflammatory airway diseases as asthma, has announced that a new randomized clinical trial shows lower incidence of asthma exacerbations and increased asthma control with Fractional exhaled Nitric Oxide (FeNO)-guided anti-inflammatory treatment.
The majority of pediatric bacterial infections that cause severe diarrhea and are potentially life-threatening occur among children who recently took antibiotics prescribed by doctors for other conditions, according to a new study by the Centers for Disease Control and Prevention published this week in Pediatrics.
GN ReSound recently launched its ReSound LiNX in global markets as a hearing aid capable of streaming high-quality stereo sound from an iPhone, iPad and iPod touch without the need for an additional pendant-like device.
Study results announced Thursday by Novo Nordisk and collaborative partners found that participation in diabetes education is associated with a greater sense of well-being and the ability to self-manage diabetes.
Most people who abuse prescription opioid drugs get them for free from a friend or relative — but those at highest risk of overdose are as likely to get them from a doctor’s prescription, Centers for Disease Control researchers reported Monday in a research letter, “Sources of Prescription Opioid Pain Relievers by Frequency of Past-Year Nonmedical Use: United States, 2008-2011,” in the Journal of the American Medical Association Internal Medicine.
In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for health of the Department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.
Physicians Interactive, a provider of online and mobile clinical resources and solutions for healthcare professionals, and McKesson Patient Relationship Solutions, a provider of pharmaceutical manufacturer-sponsored patient adherence programs, on Tuesday announced a collaboration to jointly deliver Coupons on Demand.
AstraZeneca received approval from the Food and Drug Administration for its Bydureon pen (exenatide extended-release for injectable suspension) 2-mg, which is to be used as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.
The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.
Last week, more than 30 organizations — including the American Medical Association, Infectious Diseases Society of America and Pew Charitable Trusts — urged Congressional leaders to strengthen the labeling requirements for drugs approved under the proposed Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) limited population approval pathway, which will streamline regulatory approval for antibiotics.
"The problem [of counterfeit medicines] is so big, disperse and complex that it requires a sweeping coordinated global response," wrote Scott LaGanga, executive director of the Partnership for Safe Medicines and SVP public affairs and advocacy for PhRMA in a blog published by The Hill on Saturday.