Content about Pharmacology

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

WASHINGTON — Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.

PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

NEW YORK — The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.

JERUSALEM — Teva Pharmaceutical Industries will sponsor a live audio webcast at the 2013 Barclays Global Healthcare Conference on Thursday, the Israeli generic drug maker said Tuesday.

Teva CFO Eyal Desheh will present. The company is one of several scheduled to present at the conference this week.

The webcast will be available on the company's website and is scheduled to begin at 9:30 Eastern time. An archive of the webcast will be available afterward.

ALEXANDRIA, Va. — A report on CBS' "60 Minutes" Sunday explored the aftermath of the nationwide outbreak of fungal meningitis linked to the New England Compounding Center that, according to the Centers for Disease Control and Prevention, has sickened 720 people in 20 states and led to 48 deaths.

WASHINGTON — Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

An oft-cited 1998 report, recently repeated again by the surgeon general in the January/ February 2012 "Public Health Report," estimated that 125,000 U.S. citizens die each year due to complications related to adherence. Also worrisome is the statistic that one-third to one-half of all patients don't take medication as prescribed, and according to a 2011 study by Harvard, Brigham and Women's Hospital and CVS, up to one-quarter of these never fill prescriptions at all.

PALATINE, Ill. — Acura Pharmaceuticals on Tuesday announced that its next-generation pseudoephedrine with abuse-deterrent technology will now be stocked by North Carolina's Kerr Drug. 

Nexafed is a 30 mg immediate-release pseudoephedrine product that combines effective nasal-congestion relief with a unique technology that disrupts the conversion of pseudoephedrine into methamphetamine, Acura noted. 

WASHINGTON — Nearly 98% of primary care physicians, nurse practitioners and pharmacists trust and recommend over-the-counter medicines to their patients, according to a new survey released Wednesday by the Consumer Healthcare Products Association. Nearly three-fourths of primary care physicians recommend OTC medicines to relieve symptoms before recommending a prescription treatment.