Inspections, Compliance, Enforcement, and Criminal Investigations
Xanodyne Pharmaceuticals Inc. 3-30-2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Rockville, MD 20857|
March 30, 2009
Gregory D. Flexter, President and CEO
Xanodyne Pharmaceuticals Inc.
1 Riverfront Pl.
Newport, KY 41071
Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg
Dear Mr. Flexter:
This letter is written in reference to your firm’s marketing of unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Based on the information your firm submitted to FDA's Drug Registration and Listing System, you distribute the following prescription drugs:
• Roxanol Oral Solution, 20 mg/ml;
• Roxicodone Tablets, 5 mg
As labeled, the above products are drugs within the meaning of sections 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and because they are intended to affect the structure or function of the body. Further, these drug products, as distributed by your firm, are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the product. Based upon our information, there are no FDA-approved applications on file for the above products. The marketing of these products without an approved application constitutes a violation of these provisions of the Act.
Additionally, because the above products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(l) of the Act [21 U.S.C. § 352(f)(1)]. Because your products lack required approved applications, they are not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products therefore violates sections 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
As described in the guidance entitled "Marketed Unapproved Drugs - Compliance Policy Guide"the Agency may exercise its enforcement discretion and identify a period of time during which the Agency does not intend to initiate an enforcement action against a currently marketed unapproved drug. FDA does not intend to initiate enforcement actions related to the shipment in interstate commerce of your unapproved drug products, Roxanol Oral Solution, 20 mg/ml, and Roxicodone Tablets, 5 mg, unless they are still being shipped more than 90 days after the date of this letter.
You should be aware that FDA’s enforcement discretion will not apply to the following circumstances: (1) if FDA determines that your firm is violating other provisions of the Act; (2) if it appears that your firm, in response to this letter, increases its manufacture or distribution of your unapproved products, Roxanol Oral Solution, 20 mg/ml, and Roxicodone Tablets, 5 mg, above your usual volume during these periods; or (3) if FDA learns of new information regarding any serious health risk or hazard associated with morphine sulfate drug products.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of Federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other Federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing regarding whether you plan to cease the violative activities described in this letter. If you no longer market the products referenced in this letter, your response should so indicate, including the reasons that, and the date on which, you ceased marketing. Additionally, based on our information, you do not manufacture the products listed above; therefore, your reply should include the name and address of the manufacturer. If the firm from which you receive these products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.
Your response to this letter should be directed to the attention of Ms. Sakineh Walther, Consumer Safety Officer, at the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, WO51 RM 5242, 10903 New Hampshire Avenue, Silver Spring, MD 20993.
Deborah M. Autor, Esq.
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Marketed Unapproved Drugs—Compliance Policy Guide.
Available at http://www.fda.gov/cder/guidance/6911fnl.pdf