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Business News/ Companies / News/  Lupin secures tentative FDA nod for anti-depressant drug Paxil
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Lupin secures tentative FDA nod for anti-depressant drug Paxil

Lupin can potentially market a generic version of Canada-based Apotex Technologies' anti-depressant tablet Paxil CR tablets of the same dosage

A pharmaceutical product that has tentative approval cannot be marketed or sold in the US. Photo: BloombergPremium
A pharmaceutical product that has tentative approval cannot be marketed or sold in the US. Photo: Bloomberg

New Delhi: Lupin Ltd, the country’s Mumbai-based third largest drug maker, said on Friday that it had received tentative approval from the United States Food and Drug Administration (FDA) for its Paroxetine Extended-Release Tablets USP, 12.5 mg, 25mg and 37.5 mg.

Lupin can now potentially market a generic version of Canada-based Apotex Technologies Inc.’s anti-depressant tablet Paxil CR tablets of the same dosage.

When the patents or exclusivities granted to a brand-name drug product are still enforceable, the FDA issues a ‘tentative approval letter’ to an applicant which has submitted a generic drug product application for approval.

“The tentative approval letter delays final approval of the generic drug product until all patent or exclusivity issues has been resolved. A product that has tentative approval cannot be marketed or sold in the United States," states the FDA.

Paxil is majorly used for the treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.

According to an IMS research report from June, the anti-depressant had sales of $127.4 million.

On Thursday, Apotex Corp. had also announced that it was re-entering the market with Paroxetine Controlled-Release Tablets, the authorized generic version of Paxil.

In May last year, Apotex had dragged Lupin to a Texas court in a bid to stop the latter from selling a generic version of the anti-depressant.

Apotex had claimed that it had been granted exclusive rights to manufacture Paxil by GlaxoSmithKline and that Lupin was infringing on one of the six patents covering the manufacture of Paxil.

However, in February, both parties settled the patent infringement row pursuant to undisclosed terms.

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Published: 26 Aug 2016, 05:33 PM IST
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