US FDA approves Impax’s Emverm chewable tablets to treat pinworm

Impax Laboratories, Inc., a specialty pharmaceutical company, announced that the United States Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA) for Emverm (mebendazole) 100 mg chewable tablets.

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 approximately 40 million people in the United States each year. Pinworm infection is three times more common than head lice. Emverm is not for persons who have shown hypersensitivity to the drug.

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. Albenza is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of Albenza.