Gilead Sciences, Inc. (Hogan Lovells US LLP) - Citizen Petition

This Other document was issued by the Food and Drug Administration (FDA)

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Content

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Attachments

 (7)

Gilead Sciences Inc Hogan Lovells US LLP Citizen Petition

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Authors: cder
 

Appendix A Glossary of Terms

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Tab 1 Exclusivity Summary

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Tab 2 Five Year and Three Year Exclusivity Request

Reason Restricted: This attachment is restricted to show metadata only because it contains confidential business information data.
 

Tab 3 Acknowledgement Letter to Gilead Sciences Inc NDA Approval Letter

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Tab 4 Five Year and Three Year Exclusivity Request

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Tab 5 FDA Guide

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Abstract: IND/NDA Drug Classification
 

 
 
ID: FDA-2013-P-0058-0001

Document Information

Date Posted: Jan 23, 2013
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Submitter Information

Country: United States
Submitter's Representative: Hogan Lovells US LLP
Category: Private Industry - C0003

Comments

6
Comments Received*
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Attached are comments on the Petition submitted on behalf of Novartis Pharmaceuticals Corporation (Novartis).

* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.