Cardiovascular Safety of Takeda’s Gout Drug, Uloric (febuxostat)
Read MoreAUG 3 AADPAC-DSRM
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 MoreAPR 24-25 AAC DSRM
sNDA for CELEBREX (celecoxib), by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial
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-DSRM
HYDEXOR (hydrocodone, acetaminophen, and promethazine) by Charleston Laboratories
Read MoreFEB 14 AADPAC-DSRM
HYDEXOR (hydrocodone, acetaminophen, and promethazine) by Charleston Laboratories
Read MoreNOV 1 PDAC-DSRM
Buprenorphine subcutaneous injection, submitted by Breaburn Pharmaceuticals, Inc., for treatment of opioid dependence
Read MoreOCT 31 PDAC-DSRM
Buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence
Read MoreNOV 1 PDAC-DSRM
Buprenorphine subcutaneous injection, submitted by Breaburn Pharmaceuticals, Inc., for treatment of opioid dependence
Read MoreOCT 31 PDAC-DSRM
Buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence
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 4 NDAC-DSRM
1) Safety issues with OTC analgesics for upset stomach; and 2) Hangover indications under several monographs.
Read MoreAPR 5 AADPAC-DSRM
Proposed abuse-deterrent oxycodone immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC
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