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Search Results (2986) Documents on pharmaceuticals Show: results per page Sort by:  | While We’re Waiting on Bartlett, Some New Preemption Challenges to Consider
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 21, 2013, previously published on May 20, 2013 As folks in the generic drug industry patiently await the U.S. Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-142), a design defect generic drug preemption case (see our previous post here), we thought we would whet the preemption appetite with two new...
| | Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement
John T. Bentivoglio, Jennifer L. Bragg, Maya P. Florence, Michael K. Loucks, Gregory M. Luce; Skadden, Arps, Slate, Meagher & Flom LLP;
Legal Alert/Article May 17, 2013, previously published on May 15, 2013 On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a global settlement pursuant to which Ranbaxy will pay a total of $500 million to resolve criminal and...
|  | Generic Manufacturer Ranbaxy Settles Civil and Criminal Claims Based on cGMP Violations: A New Era of cGMP Enforcement Actions?
Cathy L. Burgess, Edward T. Kang; Alston & Bird LLP;
Legal Alert/Article May 17, 2013, previously published on May 14, 2013 Yesterday, the Department of Justice (DOJ) announced that it had entered into a $500 million civil and criminal settlement with Ranbaxy USA, Inc. (Ranbaxy), the U.S. subsidiary of the largest generic drug manufacturer in India, Ranbaxy Laboratories Limited. Ranbaxy agreed to pay $350 million to...
| | FDA Determines Original OPANA ER Not Discontinued for Safety Reasons; Decision Affirms Case-by-Case Review
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 16, 2013, previously published on May 13, 2013 Late last Friday, FDA announced that the Agency denied an August 13, 2012 Citizen Petition (Docket No. FDA-2012-P-0895) submitted by Endo Pharmaceuticals Inc. (“Endo”) requesting that the Agency determine that OPANA ER (oxymorphone HCl) Extended-release Tablets approved under NDA No....
| | ALJ Essex Denies Motion For Leave To Supplement Notice Of Prior Art In Certain Reduced Folate Nutraceutical Products (337-TA-857)
John F. Presper; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article May 15, 2013, previously published on May 10, 2013 On May 8, 2013, ALJ Theodore R. Essex issued Order No. 10 denying Respondents Macoven Pharmaceuticals, LLC and Viva Pharmaceuticals, Inc.’s (collectively, “Respondents”) motion seeking leave to submit a supplemental notice of prior art in Certain Reduced Folate Nutraceutical...
| | FOIA Delays Lead to Tongue Lashing by the Fourth Circuit
Katie Bond; Hyman Phelps McNamara P.C.;
Legal Alert/Article May 13, 2013, previously published on May 9, 2013 A recent Freedom of Information Act (“FOIA”) decision from the U.S. Court of Appeals for the Fourth Circuit sends a strong message to federal agencies that the statutory time limits for FOIA responses must be honored.
| | Federal Circuit Upholds One Claim Covering Combigan
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article May 8, 2013, previously published on May 7, 2013 In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit reversed the district court in part, finding that Allergan’s composition claims and most of its method claims are invalid as obvious, but upholding one method claim because it recites a non-obvious result. Some of the court’s...
| | 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...
| | Food, Drug & Device/FDA Group Publishes cGMP Primer
Alston Bird LLP;
Legal Alert/Article May 6, 2013, previously published on May 1, 2013 Cathy Burgess, Laura Sierra and Guillermo Cuevas of the firm’s Food, Drug & Device/FDA Group, in coordination with the Food and Drug Law Institute (FDLI), have recently published How to Comply with cGMPs, a primer on standards for current Good Manufacturing Practice (cGMP) compliance.
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