Bayer's ClariSpray Brings Hint Of Familiar Brand To Nasal Allergy Space
This article was originally published in The Tan Sheet & The Rose Sheet
ClariSpray is the same formulation as GSK Consumer Healthcare's Flonase Allergy Relief, but Bayer is not making all of the same claims because OTC Flonase for another year has exclusivity among OTC intranasal corticosteroids for eye-related allergy relief.
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FDA grants Glaxo market exclusivity for OTC as the first OTC fluticasone product, but with a label carve-out that limits exclusivity to the indication of “OTC use for temporary relief of ocular symptoms due to hay fever or other upper respiratory allergies.”
OTC Umbrella Branding Soaked By Regulatory Storm In Draft Guidance – CHPA
The trade group recommends FDA write a separate proprietary name guidance for OTC drugs. FDA’s draft guidance also renders useless OTC manufacturers’ expertise in conducting tests to determine whether consumers safely self-select nonprescription drugs based on labeling, CHPA says in comments.
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...