By Kurt R. Karst – Fumble!! For years now we have discussed and tracked various FDA decisions (or non-decisions as the case may be) on what have been referred to as “180-day exclusivity punts.” These are instances in which a first applicant eligible for 180-day …
By Kurt R. Karst – For the third time this year, FDA has been asked to recognize 5-year New Chemical Entity (“NCE”) exclusivity for a fixed-dose combination drug product containing both a never-before-approved active moiety and a previously approved active moiety. In a Citizen Petition …
By Kurt R. Karst – A Citizen Petition (Docket No. FDA-2013-P-0203) submitted to FDA earlier this year raises an issue that comes up from time to time – although not typically in a public forum – about the Agency’s so-called “exception excipient” regulations applicable to sponsors …
By Kurt R. Karst – As folks in the generic drug industry patiently await the U.S. Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-142), a design defect generic drug preemption case (see our previous post here), we thought we would whet …
By Kurt R. Karst – Late last Friday, FDA announced that the Agency denied an August 13, 2012 Citizen Petition (Docket No. FDA-2012-P-0895) submitted by Endo Pharmaceuticals Inc. (“Endo”) requesting that the Agency determine that OPANA ER (oxymorphone HCl) Extended-release Tablets approved under NDA No. 021610 …
By Kurt R. Karst – Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Doctor Who, Star Wars, and, of course, Star Trek. I remember well the voyages of the starship Enterprise under the …
By Kurt R. Karst – By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013 Judgment from Judge Edward R. Korman of the U.S. District Court for the Eastern District …
By Kurt R. Karst – Frau Rommelfanger’s seventh grade German class: that’s where we first learned to appreciate “false friends,” which are pairs of words or phrases in two languages that look or sound alike, but differ significantly in meaning. Never write the word “gift” …
By Kurt R. Karst – Bayer HealthCare, LLC’s (“Bayer’s”) court challenge to FDA’s approval of Abbreviated New Animal Drug Application (“ANADA”) No. 200-495 submitted by Norbrook Laboratories, Ltd. (“Norbrook”) for Enroflox™ 100, a generic version of Bayer’s fluroquinolone animal drug Baytril® 100 (enrofloxacin) Injectable Solution, …
By Kurt R. Karst – In a brief opinion handed down last week by the U.S. Court of Appeals for the District of Columbia Circuit, the Court affirmed a July 5, 2012 decision from the U.S. District Court for the District of Columbia granting summary …
By Kurt R. Karst – The cherry blossoms are finally in full bloom in Washington, D.C., and so too is FDA’s thinking on one non-abuse-deterrent drug. In a prepublication version of a notice that will be published in the Federal Register on April 18, 2013, …
By Kurt R. Karst – “GADPTRA” – Now there’s an acronym you don’t see very often on this blog. It stands for the Generic Animal Drug and Patent Term Restoration Act of 1988, Pub. Law No. 98-417, 98 Stat. 1585 (1988), which is the Hatch-Waxman …
By Kurt R. Karst – Earlier this week, the Obama Administration released the President’s Budget for Fiscal Year 2014. At first blush, FDA appears to have fared rather well, with an additional $821,453,000 in total funding. Most of the increase, however, is due to new …
By Kurt R. Karst – A recent Complaint filed in the U.S. District Court for the Southern District of Florida by Accord Healthcare, Inc. and Intas Pharmaceuticals, Ltd. (collectively, “Accord Healthcare”) against Acorda Therapeutics Inc. (“Acorda”) and H.D. Smith Wholesale Drug Co. (“H.D. Smith”) is the …
By Kurt R. Karst – Despite amendments to the statute, court decisions, and FDA interpretations, there has been one constant throughout the nearly 29-year history of the Hatch-Waxman Amendments: dates matter. If a company – or FDA – misses a deadline by just one day, …
