By Kurt R. Karst – Every once in a while FDA gets asked a question along the lines of: “Can my company submit two ANDAs to FDA – from two different subsidiaries – each containing the same bioequivalence data?” . . . or “Can my company …
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Hatch-Waxman
- FDA’s Anti-Franchising Policy: What Is It and Where Did It Come From?March 4th, 2015
- A New Variation on an Old Theme: FDA Refuses PTE Regulatory Review Period Revision Based on Filing Refusal DecisionFebruary 24th, 2015
By Kurt R. Karst – It’s been a long time since we last posted on a Patent Term Extension (“PTE”) controversy – a little more than a year it seems (see here) – but that doesn’t mean we’re not keeping an eye on decisions coming out …
- Would You Balk at Disclosing Confidential Information to Your Competitors?February 18th, 2015
By Kurt R. Karst – Without even knowing what we’re talking about, it’s probably safe to say that any company would immediately answer “Yes!” to the question posed in the title to this post. But that’s exactly what FDA is asking some ANDA applicants to do …
- Can the AIA’s New IPR and PGR Post-Grant Proceedings Trigger a Forfeiture of 180-Day Exclusivity Under the Failure-to-Market Provisions?February 17th, 2015
By Kurt R. Karst – Last year we posted on the possible effect of Inter Partes Review (“IPR”) on the forfeiture of 180-day exclusivity eligibility under the so-called failure-to-market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I) added by the 2003 Medicare Modernization Act. With no decision …
- We Need to Move the Freight and Not be Late, Says OGD’s Uhl in GDUFA Update; But for Many in Industry, “Seeing is Believing”February 13th, 2015
By Kurt R. Karst – For those in the generic drug industry who attended the Generic Pharmaceutical Association’s (“GPhA’s”) annual meeting in Miami, Florida earlier this week, the message from Office of Generic Drugs (“OGD”) Director Dr. Kathleen “Cook” Uhl in her Generic Drug User Fee …
- FINALLY! Multiple Generic Companies Receive FDA Final Approval to Market Generic Versions of Celebrex®February 12th, 2015
By Douglas B. Farquhar, Jennifer M. Thomas & Kurt Karst – We can’t help celebrating a recent court victory in which Hyman, Phelps & McNamara, P.C. represented Mylan Pharmaceuticals, Inc. (“Mylan”), and which yesterday resulted in Final Approvals for Mylan and one other generic drug company …
- Diary of a Hatch-Waxman Addict – Day 4,079: They’re Here! FDA Finally Proposes Regulations to Implement Some of the Provisions of the 2003 MMA!February 5th, 2015
By Kurt R. Karst – There was some big news out of FDA today. Yes, there was the news that FDA Commissioner, Dr. Margaret Hamburg, one of the longest-serving FDA commissioners in the modern era (see here), has decided to resign her post effective next month. …
- Mining the Bowels of the Orange Book: What Do the Data Reveal?February 4th, 2015
By Kurt R. Karst – There’s no two ways about it: We love data. And it doesn’t really matter what FDA-related topic those data concern: citizen petitions (here and here), drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation …
- House Energy & Commerce Committee Releases 21st Century Cures Act Discussion Draft; The Nearly 400-Page Bill Includes More Proposals Than You Can Shake a Stick At!January 28th, 2015
By Kurt R. Karst – For months we have been waiting with bated breath for the promised January 2015 release of a discussion draft of legislation to implement the 21st Century Cures Initiative, which was launched in April 2014 by now-Chairman of the House Energy and …
- Whoomp! There It Is! The Other Shoe Hits the Floor as FDA Strips Ranbaxy of 180-Day Exclusivity for Generic NEXIUMJanuary 26th, 2015
By Kurt R. Karst – Earlier today (January 26, 2015), FDA announced the first approval of an ANDA for a generic version of AstraZeneca Pharmaceuticals LP's (“AstraZeneca's”) NEXIUM (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg. But it wasn’t Ranbaxy Laboratories, Ltd./Ranbaxy, Inc. (“Ranbaxy”) that scored …
- Report Card: FDA Earns a Solid “B” on Timely Responding to Section 505(w) Discontinuation Citizen PetitionsJanuary 25th, 2015
By Kurt R. Karst – It’s been a little more than 2.5 years since Section 505(w) was added to the FDC Act by Section 1134 of the 2012 FDA Safety and Innovation Act (“FDASIA”). Section 505(w), titled “Deadline For Determination on Certain Petitions,” requires FDA to …
- District Court Tackles Sticky 505(b)(2) Application Issues in an Extensive Memorandum Opinion Involving ColchicineJanuary 21st, 2015
By Kurt R. Karst – When Judge Ketanji Brown Jackson of the U.S. District Court for the District of Columbia noted in a January 12, 2015 Minute Order that the Court filed under seal a “lengthy opinion” on January 9, 2015 denying Motions for Summary Judgment …
- FDA’s Office of Generic Drugs Finally Has a Permanent Captain; Kathleen “Cook” Uhl, M.D., Named Permanent DirectorJanuary 15th, 2015
By Kurt R. Karst – The news came down on Thursday that FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., named Kathleen “Cook” Uhl, M.D., as the permanent director of the Office of Generic Drugs (“OGD”). Although Dr. Uhl has manned the helm at OGD …
- District Court Sides with FDA, 505(b)(2) Applicant in Challenge to Colchicine Capsules Approval; An Appeal is in the Works, HoweverJanuary 13th, 2015
By Kurt R. Karst – A little over three months ago, we on a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda”) filed against FDA in the U.S. District Court for the District of Columbia challenging the …
- Convergence: Recent Court Actions and Pressure From FDA May Mean the Sun is Finally Setting on the Premature Paragraph IV Notice StrategyJanuary 5th, 2015
By Kurt R. Karst – It’s been many months since we last posted on the issue of so-called “premature notice” (and over a year since we first posted on the issue). Premature notice is notice – ineffective notice – of a Paragraph IV certification sent to …