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Allegra-D Joins ‘Common Cold’ Club In OTC Antihistamine Market

This article was originally published in The Tan Sheet

Executive Summary

Allegra-D has competed in the OTC antihistamine space without including “relief of nasal congestion due to the common cold” in its indications since its 2011 launch through Sanofi’s Chattem business.

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Martek BioSciences will be the exclusive, worldwide supplier of DHA (docosahexaenoic acid) and ARA (arachidonic acid) to infant formula company Mead Johnson (Enfamil) according to a ten-year supply agreement, the firm announces May 18. The agreement is an expansion and extension of a 25-year license agreement signed in 1992. Martek's blend is the only source of these nutrients currently used in U.S. infant formula. However, Abbott Lab's Ross Products Division's (Similac) tuna oil-derived DHA and fungally-derived ARA was granted Generally Recognized as Safe status for use in infant formula by FDA May 18. Martek does not expect to lose customers to Ross because of the latter's GRAS status, the firm asserts in a same-day release. "The levels of DHA and ARA specified in the notification are significantly lower than levels used in the majority of all term and pre-term infant formula sold in the U.S.," Martek notes...

US FDA Portal Open To Receive OTC Monograph Meeting Requests

Submitting other OTC monograph program communications through CDER's NextGen Portal, including proposals to add formulations or indications to a monograph, will have to wait.

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