By Kurt R. Karst – It was just a few months ago that we posted on what might have been the first decision in a case involving a counterclaim seeking an order to correct or delete patent information from the Orange Book (and that does not …
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Hatch-Waxman
- Court Orders Orange Book Patent Delisting in NUEDEXTA Infringement Litigation; But What’s It Good For?September 4th, 2014
- The Generic Drug Labeling Carve-Out ScorecardSeptember 2nd, 2014
By Kurt R. Karst – With the recent litigation surrounding FDA’s approval of ANDAs for generic versions of PRECEDEX (dexmedetomidine HCl) Injection – which litigation has now moved on to Motions for Summary Judgment (see our updates here for the latest briefs) – we’ve had renewed …
- OGD Management Review Results in Forfeiture of Generic ACTONEL 180-Day Exclusivity EligibilitySeptember 1st, 2014
By Kurt R. Karst – The hope is that years from now (but hopefully not too many years), once the review and performance metrics FDA agreed to as part of the Generic Drug User Fee Amendments are in full effect and 10-month ANDA reviews (resulting in …
- FDA Puts Controls on Controlled Correspondence in the Agency’s Latest GDUFA OfferingAugust 27th, 2014
By Kurt R. Karst – This blogger’s oldest child started middle school this past week. Naturally, I was excited to get his impressions of the first day of school. “Good” was his initial comment – a now all too familiar one-word tween response with which I …
- Final Rule on Branded Rx Drug Fee Treats All NDAs the Same, but IRS Might Consider a Special Rule for Pre-Hatch-Waxman Paper NDAsAugust 24th, 2014
By Alan M. Kirschenbaum – Beginning with CY 2011, Section 9008 of the Patient Protection and Affordable Care Act (“ACA”) has imposed an annual fee on manufacturers and importers of “branded prescription drugs.” The global 2014 fee for all manufacturers and importers is $3 billion, to …
- In Generic PRECEDEX Litigation, Hospira Wins Temporary Restraining Order; Court Orders Recall of Generics, then BacktracksAugust 20th, 2014
By Kurt R. Karst – The pace of litigation concerning FDA’s approval of generic versions of Hospira, Inc.’s (“Hospira’s”) PRECEDEX (dexmedetomidine HCl) Injection, 100 mcg (base)/mL packaged in 200 mcg(base)/2 mL single-dose vials, has been anything but sedate. On the morning of August 18, 2014, there …
- Fuhgeddaboudit: FDA Takes a Different Road on Generic PRECEDEX and Issues Letter Decision Allowing ANDA Labeling Carve-OutsAugust 18th, 2014
By Kurt R. Karst – We were beginning to wonder whether FDA would ever issue a letter decision addressing the novel issues raised in the Agency’s January 15, 2014 “Dear NDA/ANDA Applicant” letter (Docket No. FDA-2014-N-0087) concerning approval of generic versions of Hospira, Inc.’s (“Hospira’s”) PRECEDEX …
- FDA’s Office of Generic Drugs Continues to Churn Out New and Revised Policies; Wants to Partner With Industry to Develop Best PracticesAugust 18th, 2014
By Kurt R. Karst – The folks in FDA’s Office of Generic Drugs (“OGD”) have been especially busy as of late preparing for the October 1, 2014 implementation of the review and performance metrics agreed to under the Generic Drug User Fee Amendments of 2012 (“GDUFA”). …
- Eisai Sues FDA Over NCE Exclusivity False Starts for BELVIQ and FYCOMPAAugust 10th, 2014
By Kurt R. Karst – We thought Eisai Inc.’s (“Eisai”) beef with FDA over New Chemical Entity (“NCE”) exclusivity might resurface at some point . . . and now it has. Last Friday, Eisai filed a Complaint in the U.S. District Court for the District of …
- FDA Rejects Requests to Initiate Rulemaking for 505(b)(2) NDA Therapeutic Equivalence Rating DecisionsJuly 28th, 2014
By Kurt R. Karst – In a rather lengthy (33-page) response to two citizen petitions submitted to FDA by AbbVie Inc. (Docket No. FDA-2011-P-0610) and Auxilium Pharmaceuticals, Inc. (Docket No. FDA-2013-P-0371) concerning their testosterone gel 1% drug products – AbbVie’s ANDROGEL (NDA No. 021015) and Auxilium’s TESTIM …
- FDA’s Intervening NDA Approval Policy Strikes Again; Agency Denies Antares Petition on MethotrexateJuly 20th, 2014
By Kurt R. Karst — Beginning in 1999, around the time FDA issued a (still) draft guidance document on 505(b)(2) applications, and lasting until about 2009, this blogger taught an introduction to drug law course at FDA to FDAers. The focus of my talk was – surprise, surprise …
- Yet Another Petition to FDA Says: “Gimme My 5-Year NCE Exclusivity!” But What’s it to Ya?July 16th, 2014
By Kurt R. Karst – Our FDA Citizen Petition Tracker is littered with petitions and petitions for reconsideration submitted to FDA over the past 18 months requesting that the Agency recognize a period of 5-year New Chemical Entity (“NCE”) exclusivity for certain Fixed-Dose Combination Drugs (“FDCs”) …
- FDA Issues GDUFA ANDA Amendment and PAS Guidances Explaining Implementation of Some of the More Complex Provisions of the User Fee AgreementJuly 10th, 2014
By Kurt R. Karst – Earlier this week, and just a day after the second anniversary of the 2012 FDA Safety and Innovation Act that, among other things, includes the Generic Drug User Fee Amendments (“GDUFA” ), FDA announced the release of two draft guidance documents …
- Is the Issuance of a Pediatric Written Request a Condition Precedent to FDA Awarding Pediatric Exclusivity? A New Citizen Petition Pushes FDA to Answer the QuestionJuly 1st, 2014
By Kurt R. Karst – Ever since the FDC Act was amended in November 1997 by the the FDA Modernization Act (“FDAMA”) to add a new section creating a period of “pediatric exclusivity,” we’ve had more than a passing interest in the provision. In fact, it …
- Another Federal Court Rejects the ANDA RLD Theory of Liability: The Sixth Circuit Weighs InJuly 1st, 2014
By Kurt R. Karst – It’s been quite a while since we last posted on the so-called “RLD (Reference Listed Drug) Theory of Liability.” It’s the theory put forward by plaintiffs’ attorneys in a lot of failure-to-warn generic drug product liability cases which posits that FDA’s …