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HAYWARD, Calif. — Impax Laboratories Inc. has received Food and Drug Administration approval for its supplemental new drug application for Emverm 100-mg chewable tablets, a medication for parasitic worms.
Ampex said Friday that Emverm (mebendazole) is indicated for the treatment of pinworm (Enterobius vermicularis), whipworm (Trichuris trichiura), common roundworm (Ascaris lumbricoides), common hookworm (Ancylostoma duodenale) and American hookworm (Necator americanus) in single or mixed infections.
“We are pleased to announce the approval of Emverm, a new prescription product for the treatment of pinworm and certain worm infections,” stated 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. We currently expect to initiate commercial distribution of Emverm early in the second quarter of 2016.”
The company noted that pinworm infects about 40 million people in the United States annually and is three times more common than head lice.
“As part of our life-cycle plan to enhance our anthelmintic franchise in addition to Albenza (albendazole), with this approval we can now offer an anthelmintic to treat the most common worm infections in the United States,” Wilkinson added. “Additionally, the approval of Enverm further leverages the strategic benefits of the Tower Holdings acquisition.”
