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Hyman, Phelps & McNamara, P.C. Document Search Results (253) Show: results per page Sort by:  | Generic and Innovator Drugs: The Next Generation
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 8, 2013, previously published on May 7, 2013 Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Dr. Who, Star Wars, and, of course, Star Trek. I remember well the voyages of the starship Enterprise under the command of Captain James T. Kirk (in rerun). I also remember the September 1987...
| | FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 6, 2013, previously published on May 5, 2013 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 of New York that FDA, within 30 days, make levonorgestrel-based...
| | False Friends: FDA’s “Gift” on NESINA - Present or Poison? It May Depend on Which Hatch-Waxman Language is Spoken
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 6, 2013, previously published on May 2, 2013 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” on a...
| | Senate’s HELP Committee Releases Draft Compounding Legislation; Seeks Stakeholders’ Written Comments by May 3, 2013
Karla L. Palmer; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 3, 2013, previously published on April 29, 2013 The Senate’s Health, Education, Labor and Pensions (“HELP”) Committee released draft legislation on Friday, April 26, 2013, that would replace section 503A of the Federal Food, Drug & Cosmetic Act (“FDCA”), amend other sections, and clarify FDA’s authority to...
| | Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution
Katie Bond; Hyman Phelps McNamara P.C.;
Legal Alert/Article May 3, 2013, previously published on May 1, 2013 Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention.
| | FDA to Reconsider Approval of Generic BAYTRIL; Court Gives Importance to Unresolved Citizen Petition; Will the Decision Affect FDA Petition Procedures?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 2, 2013, previously published on April 30, 2013 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...
| | Court Rules that FDA has the Inherent Authority to Rescind a 510(k) Substantial Equivalence Determination if It Does so Within a Reasonable Period of Time
Carmelina G. Allis; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 30, 2013, previously published on April 28, 2013 As we previously reported, ReGen Biologics, Inc. ("ReGen"), which has been acquired by Ivy Sports Medicine, LLC ("Ivy"), filed suit in 2011 challenging FDA’s authority to rescind the 2008 510(k) substantial equivalence determination for the company’s...
| | DC Circuit Rules for FDA in SEROQUEL Exclusivity Case; AstraZeneca Not Entitled to 3-Year Exclusivity
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 30, 2013, previously published on April 29, 2013 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 judgment for FDA in a case brought by AstraZeneca Pharmaceuticals...
| | Tracking and Tracing Congress’ New Track and Trace Bills
William T. Koustas, Jessica A. Ritsick; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 26, 2013, previously published on April 25, 2013 Within the last week, members of health committees in the House and Senate unveiled draft bills addressing prescription pharmaceutical supply chain security. The House Energy & Commerce Committee is set to hold a hearing on the House bill on April 25, 2013. Dr. Janet Woodcock, Director of...
| | Court Rules in Novel False Claims Act Case Where One Pharmaceutical Company Sues Another
Delia A. Stubbs; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 26, 2013, previously published on April 24, 2013 The U.S. District Court for the Central District of California issued a ruling last week in an unusual, if not unprecedented, case arising from alleged federal False Claims Act (“FCA”) violations where one drug manufacture has sued its competitor. In Amphastar Pharm., Inc. v. Aventis...
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