Pfizer's abuse-deterrent Troxyca ER, or oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, has been approved by the FDA to manage severe pain that requires continuous long-term opioid treatment and for which alternative treatments are inadequate. The painkiller is formulated in pellets with sequestered naltrexone hydrochloride in the core, surrounded by oxycodone hydrochloride.
Pfizer's marketing application for ALO-02, an extended-release, abuse-deterrent formulation opioid for pain management, was accepted for review by the FDA. The drug, taken orally, is a combination of oxycodone hydrochloride and naltrexone hydrochloride. The filing was based on data from two late-stage trials involving patients with moderate to severe chronic pain not caused by cancer.
Domega NY International recalled Green Day Brand Dried Coconut due to sulfites not listed on the product's label. As little as 10 milligrams of sulfites can lead to anaphylactic shock in sensitive individuals as well as severe reactions in people with asthma.
The FDA gave Sun Pharmaceutical Industries tentative approval to market a copy of Rilutek, Sanofi-Aventis' treatment for diseases of the central nervous system. The generic, which contains riluzole hydrochloride, will be sold as a 50-milligram tablet.