Akorn, Inc., a leading specialty pharmaceutical company, has launched promethazine hydrochloride and phenylephrine hydrochloride syrup (promethazine/phenylephrine) and codeine phosphate syrup CV (promethazine/phenylephrine/codeine). The launches follow approval of abbreviated new drug applications (ANDAs) for both products from the US Food and Drug Administration (FDA) in December 2014.
The two products complement Akorn's existing promethazine formulations which include promethazine HCl oral solution, USP; promethazine HCl and codeine phosphate syrup CV; and promethazine HCl and dextromethorphan HCl oral solution.
Akorn's promethazine/phenylephrine syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. Marketed under Akorn's hi-tech Pharmacal label, fruit-flavoured promethazine/phenylephrine syrup is available in a 473 ml bottle.
According to IMS Health, branded and generic sales of promethazine/phenylephrine syrup were approximately $9 million for the twelve months ended July 31, 2015.
Akorn's promethazine/phenylephrine/codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy and the common cold. Also marketed under Akorn's hi-tech Pharmacal label, fruit-flavoured promethazine/phenylephrine/codeine syrup is available in 118 ml and 473 ml bottles.
According to IMS Health, branded and generic sales of promethazine/phenylephrine/codeine syrup were approximately $16 million for the twelve months ended July 31, 2015.