- The FDA accepts for review the New Drug Application (NDA) from Teva Pharmaceutical Industries (TEVA -0.6%) for CEP-33237, its hydrocodone bitartrate extended release tablets for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- The product is formulated with its proprietary abuse-deterrent technology, although it does not specify the nature of the technology or how it works. In an oral human abuse liability study (HAL) in nondependent recreational opioid users, the abuse potential of finely crushed CEP-33237 powder was significantly lower based on peak at-the-moment drug liking. An intranasal HAL study produced the same result.
- Related tickers: (ZGNX -0.6%)(OTC:EGLT)(OTCQB:ELTP)(PFE -0.7%)(OTC:ACUR)(MNK -0.6%)(ACT +0.7%)(ABBV -0.6%)(LCI +1%)(ALKS -1.7%)
FDA accepts Teva's NDA for abuse-deterrent opioid
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