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Re: None

Tuesday, 04/15/2014 7:36:37 PM

Tuesday, April 15, 2014 7:36:37 PM

Post# of 422610
The FDA is now providing cover for ?

J,

Correct, we do not disclose filers. 21 CFR 314.430 reads:

Sec. 314.430 Availability for public disclosure of data and information in an application or abbreviated application.
(a) The Food and Drug Administration will determine the public availability of any part of an application or abbreviated application under this section and part 20 of this chapter. For purposes of this section, the application or abbreviated application includes all data and information submitted with or incorporated by reference in the application or abbreviated application, including investigational new drug applications, drug master files under 314.420, supplements submitted under 314.70 or 314.97, reports under 314.80 or 314.98, and other submissions. For purposes of this section, safety and effectiveness data include all studies and tests of a drug on animals and humans and all studies and tests of the drug for identity, stability, purity, potency, and bioavailability.

(b) FDA will not publicly disclose the existence of an application or abbreviated application before an approval letter is sent to the applicant under 314.105 or tentative approval letter is sent to the applicant under 314.107, unless the existence of the application or abbreviated application has been previously publicly disclosed or acknowledged.

(c) If the existence of an unapproved application or abbreviated application has not been publicly disclosed or acknowledged, no data or information in the application or abbreviated application is available for public disclosure.

(d)(1) If the existence of an application or abbreviated application has been publicly disclosed or acknowledged before the agency sends an approval letter to the applicant, no data or information contained in the application or abbreviated application is available for public disclosure before the agency sends an approval letter, but the Commissioner may, in his or her discretion, disclose a summary of selected portions of the safety and effectiveness data that are appropriate for public consideration of a specific pending issue; for example, for consideration of an open session of an FDA advisory committee.


Virginia L. Behr
Ombudsman
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

(301) 796-3436
Web page: CDER Ombudsman

From: J
Sent: Monday, April 07, 2014 7:09 PM
To: Young, Johnny; Margand, Iain; Behr, Virginia L
Subject: Anonymous Paragraph IV Patent Certifications


"The Agency will not disclose the identity of the applicant"


To Whom it may concern,


Amarin's exclusivity was delayed 18 months unjustly, potentially due to a 505q violation with soon to be pending antitrust litigation. Is it normal policy to withhold the ANDA filer? Please send me the appropriate MAPP outlining this guidance.


Thank You,


Williams

Paragraph IV Patent Certifications
April 7, 2014
The PDF contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/2004). The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Regulatory Support Branch at 240-276-8400, before making any decisions based on this information.

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