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US FDA clarifies deadline for "old" antibiotic patents

This article was originally published in Scrip

Executive Summary

Sponsors of "old" antibiotics must submit patent information to the US FDAby December 5th, the agency said in a draft guideline interpreting a new law. The QI Program Supplemental Funding Act, which was enacted on October 8th, amended the FD&C Act to extend Hatch-Waxman exclusivity benefits – and patent listing and certification requirements – to antibiotics submitted to the agency before November 21st, 1997 (Scrip Online, October 2nd, 2008). The measure's transitional rules provide for the submission of patent information within 60 days after enactment, FDA publication of the patent information within 90 days and certification to such patents by applicants of pending ANDAs within 120 days. The FDA said sponsors of NDAs approved on or before October 7th, 2008 containing an "old" antibiotic drug must submit patent information by December 5th.






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