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FDA has approved the Company's supplemental new drug application sNDA for EMVERM (mebendazole) 100 mg chewable tablets; commercial distribution of EMVERM expected in the early second quarter of 2016

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Management Comment "We are pleased to announce the approval of EMVERM, a new prescription product for the treatment of pinworm and certain worm infections," said Fred Wilkinson, President and Chief Executive Officer of Impax. "EMVERM is an important treatment option for pinworm as it offers a 95% clinical cure rate in a single 100 mg dose.3 We currently expect to initiate commercial distribution of EMVERM early in the second quarter of 2016."
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Related Keywords Fda, Supplemental New Drug, Emverm, Mebendazole, Enterobius Vermicularis, Pinworm, Trichuris Trichiura, Whipworm, Ascaris Lumbricoides, Common Roundworm, Ancylostoma Duodenale, Common Hookworm, Necator Americanus, American Hookworm