FDA Approves Emverm Chewable Tablets
Impax announced that the Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Emverm (mebendazole) chewable tablets.
Emverm is indicated for the treatment of pinworm (Enterobius vermicularis), whipworm (Trichuris trichiura), common roundworm (Ascaris lumbricoides), common hookworm (Ancylostoma duodenale), American hookworm (Necator americanus), as single or mixed infections.
Mebendazole is a broad-spectrum antihelmintic that inhibits the formation of the worms' microtubules and causes the worms' glucose depletion.
Emverm will be available as 100mg strength chewable tablets in 1-count blister packs. It is anticipated to launch in the second quarter of 2016.
For more information call (215) 558-4300 or visit Impaxlabs.com.