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 …
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 …
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 …
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 …
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. …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
By Kurt R. Karst – In what is, to our knowledge, a first-of-its-kind written decision, Judge Esther Salas of the U.S. District Court for the District of New Jersey issued an Oral Opinion and Order on December 22, 2014 granting without prejudice in part and denying …
By Kurt R. Karst – FDA’s Sixth Annual Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience during Fiscal Year 2013 (“FY 2013”) with citizen petitions subject to FDC Act § 505(q), though largely repetitive of reports filed for previous fiscal years …
