FDA Clears Path for Cyproheptadine HCl 4-mg Tablets

Summary

The US Food and Drug Administration (FDA) has made a determination that Periactin tablets containing 4 milligrams of cyproheptadine hydrochloride (HCl) were not withdrawn from sale due to safety or effectiveness concerns, paving the way for the approval of abbreviated new drug applications (ANDAs) for these tablets.