FDA Accepts Teva’s NDA for Abuse-Deterrent Hydrocodone

Teva Pharmaceutical Industries Ltd. reports that the US Food and Drug Administration (FDA) has accepted for review the company’s new drug application (NDA) for the company's hydrocodone bitartrate extended-release (ER) tablets formulated with Teva's proprietary abuse-deterrence technology (CEP-33237). CEP-33237 is an investigational, 12-hour, acetaminophen-free, formulation of extended-release hydrocodone for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Source: Teva

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