Blog & Resources Camargo Blog April 13th, 2009

Morphine Solution—FDA Changes Its Decision

We recently discussed FDA’s decision to remove morphine-containing products from the market. Unfortunately, this decision was made without the benefit of an NDA-approved product being available. This left a void in the market – no oral morphine solution was available for home care. Give some credit to the FDA – they swiftly reversed their decision for the morphine solution. FDA has given the manufacturers a 180 day period after an NDA has been approved.

Categories: Regulatory

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.

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