Lupin gets USFDA final nod for pain relief tablets
New Delhi : Drug firm Lupin has received final approval from the US health regulator for its Hydrocodone Bitartrate and Acetaminophen tablets used for providing pain relief.
The tablets are generic version of Allergan Sales LLC's Norco tablets in the same strengths and the product will be launched shortly, Lupin said.
Lupin Somerset has received final approval to market its Hydrocodone Bitartrate and Acetaminophen tablets USP, in the strengths of 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg from the United States Food and Drug Administration (USFDA), Lupin said in a filing to BSE.
As per IMS MAT September 2016 data, Lupin said, the tablets had US sales of USD 849.5 million.
The tablets are indicated for the relief of moderate to moderately severe pain, it added.
Lupin Ltd stock closed at Rs 1,536.60, up 3.22 per cent, on BSE.
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