NEW DELHI, Jan 23: Drug major Lupin has received final approval for generic version of anti-depressant Paroxetine Extended Release tablets from the US health regulator.
In a BSE filing, Lupin said “it has received final approval for its Paroxetin Extended Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg from the United States Food and Drug Administration (USFDA).”
The company said it will commence promoting the product shortly.
Lupin’s Paroxetin Extended Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg are the AB rated generic equivalents of Apotex Technologies, Inc’s Paxil CR Tablets, 12.5 mg, 25 mg and 37.5 mg.
It is indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.
Quoting IMS MAT September 2016 data, Lupin said, Paxil CR tablets had US sales of USD 127.7 million.