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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