News & Updates

Category: FDA

NABP e-News: Medication Disposal Site Search Tool Now Available on AWARxE Website

Dec 18, 2014 Tags: CDC, DEA, FDA, Influenza, Medicare, Pharmaceuticals

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.

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FDA Reclassifies Mallinckrodt’s Generic Version of Johnson & Johnson’s Concerta

Nov 17, 2014 Tags: FDA

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 The agency said that the change was made on the basis of new draft guidance for determining the bioequivalence of methylphenidate products published earlier this month.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.

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FDA Warns of Growing Network of Rogue Wholesale Drug Distributors

Oct 2, 2014 Tags: FDA, Pharmaceuticals

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.

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