First-In-Class Nasacort OTC Also Originates ‘Children’s’ Label
This article was originally published in The Tan Sheet
Sanofi introduces Children’s Nasacort Allergy 24HR in the same formulation and dosage as the original OTC switch, but with “children’s” added to the package after approval by FDA. The firm promotes the product as the “first and only” 24-hour multi-symptom nasal allergy spray available OTC for children ages 2 and up.
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Adulturated red yeast rice
FDA threatens enforcement action against two firms selling red yeast rice supplements adulterated with lovastatin - the active ingredient in Merck's Rx cholesterol-lowering drug Mevacor. Consumers should not purchase or consume Swanson Healthcare Products' Red Yeast Rice and Red Yeast Rice/Policosonal Complex or Sunburst Biorganics' Cholestrix since FDA testing revealed the presence of the statin, which can cause harmful side-effects such as muscle weakness and kidney issues and may interact with other medications, FDA announces Aug. 9. The agency determined the adulterated supplements are unapproved new drugs, sent warning letters to the companies marketing the products and threatens to employ enforcement actions, such as seizure of illegal products and criminal prosecution if the companies fail to resolve the violations immediately, according to the warning letters. In January 2005, Source Naturals received a courtesy letter from FDA for the same problem (1"The Tan Sheet" Jan. 24, 2005, In Brief)...
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...