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`Import Alert 66-60
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`(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer
`(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to
`bind FDA or the public).
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`Import Alert # 66-60
`Published Date: 03/18/2011
`Type: DWPE
`Import Alert Name:
`"Detention Without Physical Eamaintion of Certain Steroid Alternatives"
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`Reason for Alert:
`Unapproved alternatives to anabolic steroids have commonly been found to present serious safety and effectiveness concerns. In
`February, 1991, anabolic steroids became controlled substances. This is one factor which has stimulated the market for imported
`steroid alternatives.
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`Guidance:
`Districts may detain without physical examination all shipments of finished dosage forms (both commercial and personal) of the
`cited unapproved products. Do not collect samples for laboratory analysis. Districts should determine whether the drugs are
`covered by a current approved NDA or IND. Those products covered by an approved NDA or IND should be released.
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`Bulk forms of these drugs may be detained under certain circumstances as misbranded drugs; however, prior to initiating any
`action against bulk pharmaceutical chemicals, contact CDER's Import/Export Branch.
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`Product Description:
`Foreign manufactured unapproved drugs promoted as alternatives to certain anabolic steroids i.e.,
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`* Yohimbe Bark or Yohimbe Bark Extract
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`* Cyclofenil
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`* Gamma Hydroxybutyrate (GHB)
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`* Diosgenin
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`* Clenbuterol
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`Charge:
`"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the
`meaning of Section 201(p) without an approved new drug application [Unapproved New Drug, Section 505(a)]."
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`OASIS Charge Code - UNAPPROVED
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`Countries
`MULTIPLE COUNTRIES (PODS ONLY)
`(60 D - - 99) Adrenocortical Steroid N.E.C.
`Notes:Yohimbe Bark or Yohimbe Bark Extract Cyclofenil Gamma Hydroxybutyrate (GHB) Diosgenin Clenbuterol
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`3. http://www.fda.gov/default.htm
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`http://www.accessdata.fda.gov/cms_ia/importalert_198.html
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`JAZZ EXHIBIT 2002
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00547
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`Page 1 of 2
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`4. http://www.fda.gov/ForIndustry/ImportProgram/default.htm
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