Lannett Approved for More Hydrocodone Bitartrate/APAP Strengths
Lannett announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for additional strengths of Hydrocodone Bitartrate and Acetaminophen Tablets, 5mg/325mg, 7.5mg/325mg, and 10mg/325mg, the generic version of Allergan's Norco.
Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Hydrocodone is a full opioid agonist with relative selectivity for the mu-opioid(µ) receptor. The precise mechanism of analgesia of hydrocodone is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity are thought to play a role in the analgesic effects of this drug. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to primarily involve central actions.
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