Lupin gets US FDA’s nod for Generic Paxil CR Tablets

23 Jan 2017 Evaluate

Pharma Major Lupin 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 (US FDA) to market a generic version of Apotex Technologies, Inc’s Paxil CR Tablets, 12.5 mg, 25 mg and 37.5 mg. Lupin shall commence promoting the product shortly.

The company’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. Paxil CR Tablets had US sales of $127.7 million (IMS MAT September 2016).

Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals.

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