$NKTR For reference purposes, HERE is the argument by the FDA... NKTR-181 base and phosphate salt are controlled in Schedule II of the CSA for being a derivative of oxycodone [see 21 CFR §1308.12 (b) (1) (xiii)]. The Sponsor requested a Schedule IV designation for the drug substance NKTR-181, however, based upon examination of information provided under NDA 211802, it is advisable to keep NKTR- 181 in Schedule II.
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