FDA panel backs J&J tuberculosis drug
RARITAN, N.J. — A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.
J&J subsidiary Janssen Research & Development said the FDA’s 18-member Anti-Infective Drugs Advisory Committee voted unanimously that the results of clinical trials of the drug bedaquiline supported its approval for treating pulmonary multi-drug resistant tuberculosis as part of drug-combination therapy. The committee voted 11-7 that the drug was sufficiently safe for this use as well. The FDA isn’t required to follow advisory committee votes, but usually does.
"We are pleased with the committee’s recommendation and look forward to working with the FDA to bring this important therapy to patients who suffer from MDR-TB," Janssen global head of development for infectious diseases and vaccines Wim Parys said. "The positive recommendation from the FDA advisory committee is an important step toward achieving that goal."
Janssen said the the FDA assigned a priority review designation to the regulatory application for the drug, which the company filed in June, seeking accelerated approval.
FDA approves Mylan overactive bladder drug
PITTSBURGH — The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.
Mylan announced the approval and launch of tolterodine tartrate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Detrol, made by Pharmacia and Upjohn, now owned by Pfizer.
Used to treat overactive bladder, tolterodine tartrate tablets had sales of about $61.5 million during the 12-month period ended in September, according to IMS Health.
NCPA releases progress report on medication adherence initiative
ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday released Moving Forward on a Solid Foundation: Year One Progress Report, which examines the success of the association’s strategic initiative Pharmacists Advancing Medication Adherence.
The 16-page report covers July 2011 through July 2012 and outlines the tangible and measurable steps that are currently underway in facilitating the ability of independent community pharmacists to provide adherence services as a core competency of the profession, equivalent to the dispensing process, by 2015.
"NCPA is committed to advancing and improving patient medication adherence, which is why we launched this ambitious, comprehensive and realistic five-year program to address this problem," stated NCPA CEO Douglas Hoey. "As very accessible and highly trained medication experts that patients trust, independent community pharmacists are perfectly suited to help drive greater adherence. NCPA wants to help its members maximize their potential in this critical component of health care," he said. "We are confident that, when the five-year program concludes, the disturbing number of $290 billion a year being wasted on the improper use of medication will begin to recede and momentum for further improvement will be clear."
As part of PAMA, NCPA has launched Simplify My Meds, an adherence program that allows pharmacists to coordinate patients’ prescription refills on a single day of the month. This model facilitates a more comprehensive and coordinated level of pharmacy care, reduces the potential for gaps in therapy, and promotes improved medication adherence.
Research has confirmed that refill coordination at a single pharmacy is recognized as an effective tactic to improve adherence, and to date, more than 26,000 patients are benefiting from this service at more than 700 community pharmacies nationwide. NCPA also launched www.stick2thescript.org, an online resource that provides pharmacists and other healthcare providers with a comprehensive set of tools, programs and materials to use with patients to help them understand the goals and outcomes of their prescription regimen, manage their chronic conditions and take their medications as directed.
PAMA is supported by unrestricted grants from Cardinal Health Foundation, GlaxoSmithKline, Merck and Pfizer.