Lupin receives USFDA approval for generic Norco Tablets

05 Dec 2016 Evaluate

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.

Lupin Share Price

2151.05 19.25 (0.90%)
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