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 The agency said that the change was made on the basis of new draft guidance for determining the bioequivalence of methylphenidate products published earlier this month.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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FDA Warns Consumers About Fraudulent Ebola Treatment Products

Aug 20, 2014 Tags: CDC, FDA

The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.

There are currently no FDA-approved vaccines or drugs to prevent or treat Ebola. Although there are experimental Ebola vaccines and treatments under development, these investigational products are in the early stages of product development, have not yet been fully tested for safety or effectiveness, and the supply is very limited. There are no approved vaccines, drugs, or investigational products specifically for Ebola available for purchase on the Internet. By law, dietary supplements cannot claim to prevent or cure disease.

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FDA Approves New Extended-Release Oxycodone Drug With Abuse-Deterrent Properties

Aug 5, 2014 Tags: FDA, Pharmaceuticals

FDA approved Targiniq Extended Release (ER) (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) on July 23 — the second Extended Release/Long-Acting opioid analgesic with abuse-deterrent properties. The naloxone in Targiniq blocks the euphoric effects of oxycodone when crushed, deterring abuse. Additionally, Targiniq ER is part of the ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS), which requires further education and documentation to prescribers and patients on the safe use of Targiniq ER.

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