Food and Drug Administration (FDA) has ordered the manufacturers of certain prescription ear drops to stop making and distributing the products because they are not FDA-approved.Read more
As if health insurance wasn’t already expensive enough, health insurance companies are seeking to raise the cost 20 to 40 percent.Read more
To help visitors to WWW.AWARERX.ORG more easily find disposal locations in their area, the AWARXE® Prescription Drug Safety Program has launched a location-based search tool. Visitors who type an address, city, state, or zip code into the website’s new search tool will receive a list and map of the closest medication disposal sites. Law enforcement organizations, civic centers, and pharmacies are the most common sites where prescription drugs can be disposed of in a manner that is safe for family, friends, and the environment.Read more
Mallinckrodt said Thursday that it has been informed by the FDA that its generic attention deficit-hyperactivity disorder treatment methylphenidate may not be therapeutically equivalent to Johnson & Johnson's Concerta. The agency said that the change was made on the basis of new draft guidance for determining the bioequivalence of methylphenidate products published earlier this month.
Mallinckrodt CEO Mark Trudeau remarked that "the FDA's actions are not supported by sound scientific evidence and not consistent with the best interests of patients." The drugmaker noted that its therapy "consistently met all quality specifications and the regulatory requirements originally defined by the FDA," adding that only 68 confirmed adverse events related to a lack of efficacy have been reported among 88 million prescribed doses since the drug's launch in December 2012.
Food and Drug Administration (FDA) is warning pharmacists and other health care providers to watch for counterfeit and unapproved drugs through a new educational program known as Know Your Source. Aimed at protecting patients from unsafe and ineffective drugs, the program advises providers to only purchase drugs from wholesale drug distributors licensed in their state.Read more