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505(b)(2) Head Lice Treatment approved

FDA announced on April 9 that it had approved Sciele Pharma’s benzyl alcohol lotion, 5% for the first-line treatment of head lice.  Sciele was recently acquired by Shionogi Company.

Sciele licensed this product in July 2007 from Summers Laboratories.  The product had a PDUFA date of April 2008 but closure issues led to a revised date of July 15, 2008.  On July 16, 2008 FDA issued an approvable letter.  We are not sure what transpired in the interim to cause the delay in final approval.