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Search Results (593) Documents on Antitrust & Trade Regulation, 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....
| | 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.
| | 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.
| | 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...
| | Compounding Animal Drugs from Bulk Ingredients
Duane Morris LLP;
Legal Alert/Article April 19, 2013, previously published on April 17, 2013 Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of animal compounding, the legality of compounding animal drugs from bulk...
| | Delaware Supreme Court Holds That Chancery Court Should Have Given Preclusive Effect to California Judgment Dismissing Complaint for Failing to Plead Demand Futility
Scott Ewing, Daniel H. Gold; Haynes and Boone, LLP;
Legal Alert/Article April 15, 2013, previously published on April 11, 2013 Last week the Delaware Supreme Court held in Pyott v. Louisiana Municipal Police Employees’ Retirement System, --- A.3d ---, 2013 WL 1364695 (Del. 2013), that a Delaware derivative complaint should have been dismissed after a California federal court entered a judgment dismissing essentially...
| | Court Of Appeal Upholds City’s Ban On Medical Marijuana Dispensaries
Kronick Moskovitz Tiedemann Girard A Law Corporation;
Legal Alert/Article April 11, 2013, previously published on April 5, 2013 A cooperative corporation that operates a nonprofit medical marijuana collective challenged city ordinances that ban medical marijuana dispensaries. The court of appeal held that the ordinances are not preempted by the Compassion Use Act of 1996 (“CUA”) or the Medical Marijuana Program...
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