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The Pulse of the Pharmaceutical Industry

Aurobindo Receives FDA Approval for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg

Written by: | | Dated: Thursday, October 22nd, 2015

Dayton, N.J., October 22, 2015 – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Memantine Hydrochloride Tablets USP, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the referenced listed drug (RLD), NAMENDA® Tablets, 5 mg and 10 mg, of Forest Labs.

Memantine Hydrochloride Tablets USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

The product has an estimated market size of $1.23B for the twelve months ending August 2015 according to IMS*.

Memantine Hydrochloride Tablets USP represents the latest addition to Aurobindo’s broad line of vertically integrated pharmaceuticals. Aurobindo’s product portfolio consists of 190 final approvals, including 27 tentative approvals and 10 from Aurolife Pharma LLC. There are 129 additional products on file with U.S. FDA.


* IMS National Sales Perspectives: Retail and Non-Retail MAT August 2015



Package Insert

FDA Approval Letter

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