Opioid controversy
March 14, 2014
The US Food and Drug
Administration (FDA) has generated
a storm around an opioid approval
in the face of misuse, abuse and
overdose deaths.
According to Medscape, the
agency earlier announced tighter
safety labelling on extended-release/
long-acting (ER/LA) opioids,
and just a month later, announced
plans to change the scheduling
for hydrocodone combination
medications such as Vicodin
(AbbieVie) from Schedule III to
Schedule II, increasing the security
measures to prevent misuse.
However, a controversy rages
over the FDA’s February decision
to approve a single-entity ER
hydrocodone product (Zohydro ER,
Zogenix Inc), a product without
abuse-deterrent technology.
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