Alfin Inc &lt;AFN> said it has received a regulatory letter from the Office of Compliance of the U.S. Food and Drug Administration asserting that because of labelling and certain advertising claims its Glycel products are new drugs within the meaning of the Federal Food Drug and Cosmetic Act for which no approval has been obtained and are misbranded in their labelling. The company said it understands that this action is part of an industry-wide investigation. The company added it is reviewing the matter with counsel intends to respond and take corrective action if necessary.
ALFIN <AFN> DRUG MISLABELLED, SAYS FDA