The Food and Drug Administration on Thursday announced it required Sunovion Pharmaceuticals, manufacturer of the sleep drug Lunesta (eszopiclone), to change the drug label and lower the current recommended starting dose.
The National Association of Chain Drug Stores announced that Ben Bernanke, chairman of the Federal Reserve System from 2006 to 2014, will address the NACDS Total Store Expo during the morning Business Program on Aug. 24 at the Boston Convention and Exhibition Center in Boston.
Pfizer announced plans to submit a new drug application with the Food and Drug Administration for palbociclib, which is used for the first-line systemic treatment of post-menopausal women with advanced or metastatic breast cancer.
The Centers for Disease Control and Prevention on Wednesday released guidance advising practitioners to offer an HIV prevention pill to healthy individuals who are at high risk for an HIV infection, according to published reports.
The Generic Pharmaceutical Association lobbied for greater access to generics at this week’s meeting of the chief negotiators of the Trans-Pacific Partnership in Ho Chi Minh City, Vietnam, the association announced Wednesday.
Teva Pharmaceutical was denied in its suit to block approval of Mylan's and Sandoz' generic Copaxone, a multiple sclerosis, drug 10 days before the patent on the medication expires, according to a Bloomberg report published Thursday morning.
Actavis on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for a generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride extended-release tablets 8 mg, 12 mg and 16 mg).
About half of all Americans reported taking one or more prescription drugs in the past 30 days during 2007-2010, and 1-in-10 took five or more, according to "Health, United States, 2013," the government’s annual, comprehensive report on the nation’s health that was released Wednesday.
The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday.
Teva Pharmaeceuticals on Tuesday announced that the Food and Drug Administration accepted the company's supplemental new drug application for a lower dose QNASL (beclomethasone dipropionate) nasal aerosol, which is used for the treatment of seasonal and perennial allergic rhinitis in children ages 4 years to 11 years.
The Consumer Healthcare Products Association on Friday filed comments to the Food and Drug Administration in response to the agency’s Notice of Public Hearing and Request for Comments on the Over-the-Counter Drug Monograph System, also referred to as the OTC Drug Review.
A new study from the Centers for Disease Control and Prevention found that flu vaccines prevent flu-associated hospitalizations in people 65 years and older, even during seasons when vaccine effectiveness is low, the agency stated Friday.
Working-age adults with disabilities who do not get any aerobic physical activity are 50% more likely than their active peers to have a chronic disease — such as cancer, diabetes, stroke or heart disease — according to a Vital Signs report released earlier this week by the Centers for Disease Control and Prevention.
Propeller Health, the FDA-cleared digital health solution for chronic respiratory disease, earlier this week announced that the Food and Drug Administration granted 510(k) clearance to market its latest generation of the Propeller platform, including a new sensor.
The National Association of Chain Drug Stores and a national coalition working to achieve “provider status” for pharmacists under Medicare Part B have asked the Federal Trade Commission to back legislation to this effect, as well as other policies that would help pharmacists practice at the top of their education level, NACDS reported Thursday.
Walgreens' new store format encouraging pharmacists to practice at the top of their license has passed muster with the Department of health and Human Services, The Wall Street Journal reported Wednesday.
The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted 11-4 opposed to switching Merck's allergy remedy Singulair from Rx-to-OTC, according to an Associated Press report.
Representatives of the National Association of Chain Drug Stores were among those invited to a May 1 reception — attended by President Obama and the First Lady — to thank those who worked to smooth the experience of patients with the transition to exchange-based insurance at the beginning of this year.
Seattle Mayor Ed Murray on Thursday unveiled a plan to increase the city’s minimum wage to $15. Although Murray said the hike has broad support across local government, business and labor communities, the City Council still has to vote on the proposal.