The US Food and Drug Administration (FDA) has approved Elite Pharmaceuticals' supplemental application for naltrexone hydrochloride 50 mg tablets.
Naltrexone, an opioid receptor antagonist, is used primarily to manage alcohol dependence and opioid addiction.
The approval will allow Elite to begin the commercial manufacturing and packaging of the naltrexone tablets for its sales and marketing partner, which will distribute the product as part of a multi-product distribution agreement.
Elite, which develops oral sustained and controlled release products, has five commercial products with two additional products under review, pending approval by the FDA.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-elite-supplemental-application-for-naltrexone-tablets-070213
