Blog & Resources Camargo Blog September 28th, 2007

FDA Moving Against Unapproved Hydrocodone Products

FDA is announcing that it intends to remove all unapproved products containing hydrocodone from the market. The FDA intends to swiftly move against products labeled for use in children under 6 years of age and allow 90-180 days for products not labeled for use in children under 6 years of age.

Manufacturers wishing to market these drugs must obtain FDA approval, usually through a 505(b)(2) submission. I caution that the FDA standards for these drugs are the same as any other drug. Manufacturers wish that the FDA would consider the long marketing history as evidence of safety and efficacy. That is simply not the case. FDA relies on controlled studies, including placebo where required. We have seen cases where just a pharmacokinetic study is needed, but Camargo had to develop a huge amount of publicly available data. This study and the ancillary work cost over $750,000 – worth it for the size of the market, especially if FDA moves to remove the unapproved products. This takes a market of many products and makes it a monopoly. A great investment if it works out.

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