Wednesday, April 17, 2013

Original Oxycontin discontinued for safety reasons - A blow for generic players

FDA has determined that OXYCONTIN (oxycodone hydrochloride controlled-release) Tablets, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg, approved under NDA No. 020553, have been discontinued for reasons of safety or effectiveness. Though Original OxyContin has the same therapeutic benefits as reformulated OxyContin, but original OxyContin,  poses an increased potential for abuse by certain routes of administration, when compared to reformulated OxyContin.  Based on the totality of the data and information available to the Agency at this time, FDA concludes that the benefits of original OxyContin no longer outweigh its risks.


FDA’s decision was made in response to several Citizen Petitions submitted to the Agency over the past 12 years (Docket Nos. FDA-2001-P-0238, FDA-2010-P-0526, FDA-2010-P-0540, and FDA-2011-P-0473), but primarily after FDA approved NDA No. 022272 on April 5, 2010 for a reformulated version of OXYCONTIN with physicochemical properties that are intended to make the drug product more difficult to manipulate for purposes of abuse or misuse.

As a result, original OXYCONTIN will be removed from the Orange Book entirely and FDA will not approve any ANDA for a generic version of the drug product.  




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