Lannett announced that the US Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Cyproheptadine HCl Syrup 2 mg/5 mL, the generic for Merck’s Periactin Syrup 2 mg/5 mL. The new approval is a therapeutic equivalent to the reference standard drug, Cyproheptadine HCl Syrup manufactured by Lyne Laboratories.
Cyproheptadine is a serotonin and histamine antagonist with anticholingeric and sedative effects. It is used to treat various allergic reactions such as perennial and season allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis due to inhaled allergens or foods. It can also be used to treat mild, uncomplicated allergic skin reactions such as urticaria and angioedema, ameliorate allergic reactions to blood or plasma, cold urticaria, and dermatographism. In addition, it can be used as adjunct to epinephrine and other standard measures after the acute manifestations have been controlled.
Cyproheptadine HCl Syrup will be available in a 2 mg/5 mL strength mint-flavored solution in 473 mL bottles.
Lannett receives approval for cyproheptadine hydrochloride syrup, 2 mg/5 mL [news release]. Philadelphia, PA: Lannett; July 14, 2017.
This article originally appeared on MPR