`
`Import Alert 66-60
`
`1
`
`• •
`
`2
`•
`FDA Home3Import Program4Import AlertsImports Alerts by NumberImport Alert
`
`(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).
`
`Import Alert # 66-60
`Published Date: 03/18/2011
`Type: DWPE
`Import Alert Name:
`"Detention Without Physical Eamaintion of Certain Steroid Alternatives"
`
`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.
`
`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.
`
`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.
`
`Product Description:
`Foreign manufactured unapproved drugs promoted as alternatives to certain anabolic steroids i.e.,
`
`* Yohimbe Bark or Yohimbe Bark Extract
`
`* Cyclofenil
`
`* Gamma Hydroxybutyrate (GHB)
`
`* Diosgenin
`
`* Clenbuterol
`
`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)]."
`
`OASIS Charge Code - UNAPPROVED
`
`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
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`http://www.accessdata.fda.gov/cms_ia/importalert_198.html
`
`JAZZ EXHIBIT 2002
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
`
`Page 1 of 2
`
`
`
`4. http://www.fda.gov/ForIndustry/ImportProgram/default.htm
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`
`• Accessibility
`
`• Contact FDA
`
`• Careers
`
`• FDA Basics
`
`• FOIA
`
`• No Fear Act
`
`• Site Map
`
`• Transparency
`
`• Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Email FDA
`
`For Government
`
`• • • • • • • •
`
`• For Press
`
`• Combination Products
`
`• Advisory Committees
`
`• Science & Research
`
`• Regulatory Information
`
`• Safety
`
`• Emergency Preparedness
`
`• International Programs
`
`• News & Events
`
`• Training and Continuing Education
`
`• Inspections/Compliance
`
`• State & Local Officials
`
`• Consumers
`
`• Industry
`
`• Health Professionals
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/ForIndustry/ImportProgram/default.htm
`
`http://www.accessdata.fda.gov/cms_ia/importalert_198.html
`
`Page 2 of 2
`
`Page 2 of 2
`
`Page 2 of 2
`
`Page 2 of 2
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
