Crosswalk consideration at December 17, 2015 meeting Voted to approve for Crosswalk Oxycodone Crush-resistant OxyContin Purdue Tablet consideration at ER Formulation January 7, 2016 meeting to approve for Crosswalk Hydrocodone Crush-resistant Hysingla ER Purdue Tablet consideration at ER Formulation December 17, 2015 meeting Voted to approve Morphine ER for Crosswalk Embeda Pfizer and Capsule Antagonist consideration at Naltrexone January 7, 2016 meeting Slide 6 Therapeutically Equivalent Substitutes Abuse-Deterrent Claims no FDA-Approved Labeling List of Medications with Abuse-Deterrent Claims in FDA-Approved Labeling Method of Product Manufacturer Ingredient(s) Dose Form Abuse DFC Action Name Deterrence For review at Opana ER Endo Oxymorphone Tablet February 4, 2016 formulation Meeting Aversion technology For review at Oxycodone Oxaydo Egalet Tablet with assumed February 4, 2016 ER ADF Meeting properties For review at Crush-resistant Nucynta ER Jansen Tapentadol Tablet February 4, 2016 formulation Meeting To be considered Pernix Hydrocodone BeadTek at Zohydro ER Capsule Therapeutics ER Technology February 18, 2016 Meeting To be considered Buprenorphine Sublingual Zubsolv Antagonist at and Naloxone Tablet February 18, 2016
Crosswalk consideration at December 17, 2015 meeting OxyContin Purdue Oxycodone ER Tablet Crush-resistant Formulation Voted to approve for Crosswalk consideration at January 7, 2016 meeting Hysingla ER Purdue Hydrocodone ER Tablet Crush-resistant Formulation to approve for Crosswalk consideration at December 17, 2015 meeting Embeda Pfizer Morphine ER and Naltrexone Capsule Antagonist Voted to approve for Crosswalk consideration at January 7, 2016 meeting Slide 6 Therapeutically Equivalent Substitutes Abuse-Deterrent Claims no FDA-Approved Labeling List of Medications with Abuse-Deterrent Claims in FDA-Approved Labeling Product Name Manufacturer Ingredient(s) Dose Form Method of Abuse Deterrence DFC Action Opana ER Endo Oxymorphone Tablet formulation For review at February 4, 2016 Meeting Oxaydo Egalet Oxycodone ER Tablet Aversion technology with assumed ADF properties For review at February 4, 2016 Meeting Nucynta ER Jansen Tapentadol Tablet Crush-resistant formulation For review at February 4, 2016 Meeting Zohydro ER Pernix Therapeutics Hydrocodone ER Capsule BeadTek Technology To be considered at February 18, 2016 Meeting Zubsolv Buprenorphine and Naloxone Sublingual Tablet Antagonist To be considered at February 18, 2016