Announced last Friday, Zohydro will become the first FDA-approved non-combination (not combined with analgesics like acetaminophen) and extended-release hydrocodone product.
The decision is particularly eyebrow-raising as only one day prior, the regulator issued a statement announcing it would aim to tighten the control of hydrocodone-combination products (like Vicodin) in an effort to reduce misuse and abuse by moving these products to Schedule II from Schedule III.
Schedule II drugs—part of the Controlled Substances Act—are classified as having a “high potential for abuse” and that abuse of those drugs could lead to “severe psychological or physiological dependence,” under the Controlled Substances Act. Cocaine and methamphetamine, among others, are classified as Schedule II.
