2006P-0511 Stay any action to grant approval for Oxycodone Hydrochloride extended release tablets, ANDA 77-822
FDA Comment Number : EC3
Submitter : Ms. Karla Iverson Date & Time: 01/19/2007 10:01:33
Organization : Ms. Karla Iverson
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As both a health professional and a person with Fibromyalgia, I question withholding approval for the extended release formula for pain medication that is already on the market. As you may or may not know, if pain relief can be provided in measured doses for an extended period of time, the person who lives with chronic pain has a higher quality of life. If this product is faulty, then please do withhold approval. However, if it works, most of us who have chronic pain would appreciate taking fewer pills that last longer.