Close
Blog & Resources Camargo Blog April 13th, 2009

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.



Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.


Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


Contact
Headquarters
9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights