Thursday, 19 March 2009

Citizen petition on Minocycline, Doxycycline, Mycophenolate and Clindamycin: USFDA denied innovator’s petition on 30 month stay

On March 17, 2009 USFDA denied innovator’s like Medicis (on Minocycline), Warner chilcott (Doxycycline) and Roche’s (Mycophenolate and Clindamycin) citizen petition against ANDA’s which contains a Paragraph IV certification to a patent listed in the Orange Book under the transition rules of § 4(b)(1) of the QI Program Supplemental Funding Act of 2008.
Innovator requested in the citizen petitions that USFDA should interpret the QI Act , wherein, patents listed pursuant to QI Act § 4(b)(1) should be treated as having been filed with the original NDA, thus providing for 30-month stay on ANDA approval process of generic companies who had filed ANDA on old antibiotic products before implementation of Q1 programme

Orange Book blog Here

FDA law blog Here

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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