Lupin has received final approval for its Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg from the United States Food and Drug Administration (FDA) to market a generic equivalent of Allergan Sales LLC's Norco Tablets 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg. The company shall launch the product shortly.
Lupin's Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg are the AA rated generic equivalent of Allergan Sales LLC's Norco Tablets 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg. It is indicated for the relief of moderate to moderately severe pain. Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg had US sales of $ 849.5 million as per IMS MAT September 2016.
Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals.