Results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS)
Read MoreJUN 26 AADPAC-DSRM
Remoxy ER (oxycodone extended-release capsules), submitted by Pain Therapeutics
Read MoreMAY 22 AADPAC-DSRM
Buprenorphine sublingual spray, by INSYS Development Company, for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate
Read MoreFEB 14 AADPAC
sNDA for EXPAREL (bupivacaine liposomal injectable suspension) by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia
Read MoreFEB 14 AADPAC-DSRM
HYDEXOR (hydrocodone, acetaminophen, and promethazine) by Charleston Laboratories
Read MoreFEB 14 AADPAC-DSRM
HYDEXOR (hydrocodone, acetaminophen, and promethazine) by Charleston Laboratories
Read MoreSEP 14 AADPAC-DSRM
Review of pediatric study of Butrans (buprenorphine transdermal) by Purdue Pharma L.P. for management of pain
Read MoreSEP 14 AADPAC-DSRM
Review of pediatric study of Butrans (buprenorphine transdermal) by Purdue Pharma L.P. for management of pain
Read MoreSEP 14 AADPAC-DSRM
Review of pediatric study of Butrans (buprenorphine transdermal) by Purdue Pharma L.P. for management of pain
Read MoreJUL 26 AADPAC-DSRM
Intellipharmaceutics Corp.'s, oxycodone hydrochloride extended-release oral tablets
Read MoreJUL 26 AADPAC-DSRM
Intellipharmaceutics Corp.'s, oxycodone hydrochloride extended-release oral tablets
Read MoreJUL 26 AADPAC-DSRM
Intellipharmaceutics Corp.'s, oxycodone hydrochloride extended-release oral tablets
Read MoreAPR 5 AADPAC-DSRM
Proposed abuse-deterrent oxycodone immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC
Read MoreAPR 5 AADPAC-DSRM
Proposed abuse-deterrent oxycodone immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC
Read MoreJUL 28 AAPAC-DSRM
Dynavax Technologies Corporation's HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)]
Read MoreAPR 5 AADPAC-DSRM
Proposed Abuse-Deterrent Opioid by Inspirion Delivery Sciences
Read MoreMAR 13-14 AADPAC-DSRM
1) Safety issues with Endo's OPANA ER (extended-release (ER) oxymorphone) 2) abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products
Read MoreMAR 13-14 AADPAC-DSRM
1) Safety issues with Endo's OPANA ER (extended-release (ER) oxymorphone) 2) abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products
Read MoreMAR 13-14 AADPAC-DSRM
1) Safety issues with Endo's OPANA ER (extended-release (ER) oxymorphone) 2) abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products
Read MoreMAR 13-14 AADPAC-DSRM
1) Safety issues with Endo's OPANA ER (extended-release (ER) oxymorphone) 2) abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products
Read More