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    Every once in a while we come across an instance in which FDA’s Paragraph IV Patent Certifications List does not comport with our own 180-Day Exclusivity Tracker. Either the date on FDA’s list is different from the date we have (perhaps because of a change FDA made in a subsequent version of the List), or FDA’s List simply does not identify a drug and date listing that we believe should be there. That, of course, piques our interest; and it leads to research so that we can get clarification. The “old antibiotic” Azithromycin for Oral Suspension, both 100 mg/5 m L and 200 mg/5 m L strengths, which are generic versions of Pfizer, Inc.’s (“Pfizer’s”) ZITHROMAX (approved under NDA 050710 on October 19, 1995), are two such drug products. As folks might recall, nearly a decade ago Congress passed the QI Program Supplemental Funding Act of 2008 (“the QI Act”). The QI Act amended the FDC Act to add new § 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for so-called “old antibiotics.” “Old antibiotics” are antibiotic active ingredients (and derivatives of such ingredients) included in an application submitted to FDA for review prior to November 21, 1997, the date of enactment of the FDA Modernization Act. The 1984 Hatch-Waxman Amendments excluded antibiotic drugs, which were then approved under FDC Act § 507, from the Act’s patent and non-patent market exclusivity provisions (except for the availability of a patent term extension). Azithromycin recall - sertraline with alcohol FDA's Ruling on Generic ZITHROMAX 180-Day Exclusivity A Little. Z-Pak Zithromax Heart Damage Lawsuit - fda-recalls.us
     
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