Lupin receives US FDA approval for Generic Norco

Mumbai based generic drug major, Lupin in an exchange filing post market hours on Monday, 05 December 2016 informed of receiving final approval from the US drug regulator for its Hydrocodone Bitartrate and Acetaminophen tablets.

The approval granted for the drugs are a generic equivalent of Allergan Sales LLC’s Norco Tablets of different dosages. The company plans to launch the product shortly in the world’s largest healthcare market.

Lupin’s Hydrocodone Bitartrate and Acetaminophen tablets are used for the relief of moderate to moderately severe pain.

The approval holds importance as the combined sales of the generic versions of the medicine was of USD 849.5 million as per IMS MAT September 2016 report.

Of late the pharma major has received a spurt of good news with respect to regulatory concerns being successfully addressed at its Goa facility, and bagging drug approvals from the US watchdog, in addition to the various partnerships and tie-ups the company has entered in recent months.

All these developments can be easily attributed to the returns the stock has generated in the past month as Lupin has outperformed the benchmark indices compared to broader market Nifty.

Shares of Lupin closed with gains of three percentage points at Rs 1536 on NSE.