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Ulesfia Approval History

FDA Approved: Yes (First approved April 9, 2009)
Brand name: Ulesfia
Generic name: benzyl alcohol
Dosage form: Lotion 5%
Previous Name: Summers’ Lice Asphyxiator
Company: Sciele Pharma, Inc.
Treatment for: Lice

Ulesfia (benzyl alcohol) Lotion is a non-toxic, insecticide-free head lice treatment which prevents lice from closing their spiracles (sophisticated breathing apparatus) thereby killing the lice by asphyxiation.

Development History and FDA Approval Process for Ulesfia

DateArticle
Apr 13, 2009Approval Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment
Jul 16, 2008Sciele Pharma Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment
Feb 20, 2008Sciele Provides Update on Head Lice Asphyxiation Product
Aug 16, 2007Sciele Pharma Announces FDA Acceptance of NDA for Summers Laboratories' Head Lice Treatment

Further information

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