Flonase Switch Approved, Branded Nasal Allergy Spray Market Will Grow In 2015
This article was originally published in The Tan Sheet
Glaxo says Flonase Allergy Relief (fluticasone propionate 50 mcg spray) is the “first OTC nasal spray indicated for relief of all nasal and eye-related allergy symptoms.” The firm has not learned from FDA whether Flonase Allergy Relief will launch with market exclusivity.
You may also be interested in...
Since 2012, No Shortage Of Variety In US OTC Switches While Short Of Chronic Conditions
From intranasal corticosteroids to a lice treatment, and from an addition to the OTC PPI market to the first nonprescription acne drug reaching the market through an NDA, US OTC switches in the past 10 years, since FDA began considering widening switch opportunities, haven’t lacked for variety.
Sanofi Sues FDA To Stop Publication Of Nasacort Labeling Before Launch
After FDA denied Sanofi three years of market exclusivity for OTC Nasacort, the firm filed suit against the agency not to publish the product’s labeling prior to the launch. If successful, the firm could postpone the launch of generic competition.
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...