Lupin receives US FDA pain killer drug

Lupin Limited announced that Lupin Somerset (also known as Novel Laboratories Inc) has received final approval for its hydrocodone bitartrate and acetaminophen tablet in strengthen of 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg from the US Food and Drug Administration (FDA). The approved product, which is a generic equivalent of Allergan Sales LLC’s Norco tablets, is expected to be launched shortly.

Lupin’s hydrocodone bitartrate and acetaminophen tablet is indicated for the relief of moderate to moderately severe pain.

Hydrocodone bitartrate and acetaminophen tablets - 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg - had US sales of $ 849.5 million, according to IMS MAT September 2016.