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The FDA approved Egalet’s extended-release morphine tablet, Arymo ER, for daily, around-the-clock pain treatment, with labeling describing physical properties that can deter abuse through injection. However, abuse by nasal and oral routes is still possible, the agency said. Read More
Sponsors pursuing approval of new drugs that demonstrate central nervous system activity should expect to perform thorough assessments of any potential for abuse, and be aware of specific NDA requirements. Read More
The European Medicines Agency saw a 28 percent increase in the number of applications for orphan product designations in 2016 compared to the previous year. Read More