FDA今天宣布他们对8家公司发出了警告信，因为这些公司非法销售含有缓解疼痛的布洛芬的外用OTC药物。

The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling, formulations, and indications. Ibuprofen is not included in any OTC drug monograph. Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.

这些药物是由布洛芬结合许多其他的活性成份构成的，用来缓解疼痛，但是它们并没有获得注册新药的许可，因而是非法的。在OTC类药物专著系统规定内，FDA允许一些OTC药物在没有获得批准前上市。这些药物必须遵循专著系统——关于药物的标签、成份及适应症的规定。没有任何一个OTC专著包括布洛芬。如果制药公司希望标记OTC但没有达到专著要求的，均可以提交新药上市的申请和获得注册新药的许可。

“These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug uation and Research.

FDA药品评价与研究中心法规管理处主任Deborah M. Autor说：“这些公司有职责向公众向FDA声明他们的药物是安全的和有效的，但是他们并没没有这样做。”

Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency uated what side effects might be associated with such products.

口服布洛芬已被证实是一种安全有效的解热镇痛方式。外用布洛芬还没有获得许可。虽然FDA已
提出将口服布洛芬加到OTC专著里，但并没有提出将外用布洛芬加到任何OTC专著里。外用布洛
芬被认为是一种更“安全”的，可替代口服的给药方式，因为口服会出现诸如胃溃疡、心血管效应（延长用药时间）等副作用。但是关于外用布洛芬的安全声明并没有送给FDA审核，FDA也没有评估这类药会产生何种副作用。

The names of the products and manufacturers that received warning letters are:

含有布洛芬的药物及收到警告信的生产厂商的名单：
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème(BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix  Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)

The FDA warning letters advise the companies that they may not continue to market their products without FDA approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future.

FDA警告信建议这些公司在没有获得许可前停止销售该类药物。FDA要求这些公司在15个工作日
内给出已接到警告信的书面回复及发表公司将会怎样处理这种违规行为和制止此类事件再次出现的声明。

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179689.htm

另外，国内已上市的局部用布洛芬产品主要有布洛芬搽剂、布洛芬凝胶剂、布洛芬乳膏、小儿布洛芬栓等，均为OTC药品。