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Impax Laboratories wins US FDA approval for sNDA for EMVERM for treating pinworm and certain worm infections.

M2 EQUITYBITES-January 18, 2016-Impax Laboratories wins US FDA approval for sNDA for EMVERM for treating pinworm and certain worm infections

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Pharmaceutical company Impax Laboratories (NasdaqGS:IPXL) disclosed on Friday that it has received US Food and Drug Administration (FDA) supplemental new drug application (sNDA) for EMVERM (mebendazole) 100 mg chewable tablets for the treatment of pinworm and certain worm infections.

The company said EMVERM is indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections.

Pinworm is a highly contagious parasite that infects about 40m people in the US each year and is three times more common than head lice, said the company.

ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. ALBENZA is also indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus, concluded the company.

According to CEO Fred Wilkinson, the company is pleased to announce the approval of EMVERM, a new prescription product for the treatment of pinworm and certain worm infections. EMVERM offers a 95% clinical cure rate in a single 100 mg dose in pinworm. It expects to initiate commercial distribution of EMVERM in the Q2 2016.

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Publication:M2 EquityBites (EQB)
Date:Jan 18, 2016
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