Customer Support: 800-526-4902
 





Practice Area Resource Centers

We currently offer the following Practice Areas: Litigation; Intellectual Property; Real Estate; Corporate Law; Bankruptcy; Business Law; Insurance; Taxation and more...

 






Join Matindale-Hubbell Connected



Search Results (2986)

  
Documents on pharmaceuticals
 

View Page: 1  2  3  4  5  6  7  8  9  10  Next  >>
Show: results per page
Sort by:
Sponsored Results

HTMLWhile 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...

 

HTMLRanbaxy 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...

 

Adobe PDFGeneric 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...

 

HTMLFDA 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....

 

HTMLALJ 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...

 

HTMLFOIA 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.

 

HTMLFederal 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...

 

HTMLFDA 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...

 

HTMLFalse 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...

 

Adobe PDFFood, 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.

 


View Page: 1  2  3  4  5  6  7  8  9  10  Next  >>