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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Prescription Drugs and Biologics
- 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 …
- Who can Recall what FDA’s Mandatory Recall Authority is? A U.S. District Court Could Not…August 27th, 2014
By David C. Gibbons – It is rare that we urge our readers to keep a copy of a court ruling or brief. A Brief that FDA filed on August 21, 2014 is an exception. Companies and others should read this brief and keep it close …
- 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”). …
- Rising to New Heights (And Sinking to New Lows): PDUFA, BsUFA, and GDUFA Fiscal Year 2015 User Fee Rates . . . And MoreAugust 14th, 2014
By Kurt R. Karst – For several years now we’ve closely tracked the changes in user fees rates FDA sets each fiscal year under the Prescription Drug User Fee Act (“PDUFA”). Last year, we added rates set pursuant to the Generic Drug User Fee Amendments of …
- How Rare is the MC-to-PC Basis for Demonstrating that Two Drugs Are Not the Same Orphan Drug? Another Precedent SurfacesAugust 14th, 2014
By Kurt R. Karst – The Major Contribution to Patient Care (“MC-to-PC”) basis for demonstrating that an orphan drug is clinical superiority, and is therefore not the “same drug” as a previously approved orphan drug containing the same active moiety, is supposed to be a pretty …
- 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 Was For PROCYSBI Orphan Drug Designation Based on Clinical Superiority Before It Was Against It . . . And Then For It AgainAugust 3rd, 2014
By Kurt R. Karst – “Driveway moments” – most of us have had them. It’s that moment when we feel compelled to stay in the car and finish listening to something on the radio. This blogger recently had such a moment commuting home from work on …
- “Pedigree Nouveau” Must Be Uncorked January 1July 30th, 2014
By Douglas B. Farquhar – While Wikipedia tells us that this year’s Beaujolais Nouveau will best be consumed during a flexible time period beginning November 21, drug manufacturers and drug wholesalers should be warned that there is less flexibility in an important deadline for the “pedigree …
- 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 …