Search Results for:
Kurt R Karst
(277)
- Page 5
ARTICLES(277)
-
DC District Court Sews Up Generic VANCOCIN Litigation; Decision Merely Refines and Adds New Details to Previous Preliminary Injunction Decision
- January 17, 2013
- LEGAL ALERTS/ARTICLES
-
FDA Sets GDUFA Fiscal Year 2013 Facility User Fee Rates; Fewer Facilities Result in Higher Rates
- January 17, 2013
- LEGAL ALERTS/ARTICLES
-
A Pre-MMA 180-Day Exclusivity Punt? What Gives?
- January 11, 2013
- LEGAL ALERTS/ARTICLES
-
When is 5-Year NCE Exclusivity Less Than 5 Years?
- January 11, 2013
- LEGAL ALERTS/ARTICLES
-
FDA and Ranbaxy Prevail in Dispute Over Generic DIOVAN 180-Day Exclusivity; Court Grants Motions for Summary Judgment
- January 07, 2013
- LEGAL ALERTS/ARTICLES
-
Trade Groups Sue Alameda County Over Drug Take-Back and Disposal Ordinance
- December 21, 2012
- LEGAL ALERTS/ARTICLES
-
“No-AG” Agreements are Not “Reverse Payments” Subject to Antitrust Scrutiny Says District Court in LAMICTAL Litigation
- December 18, 2012
- LEGAL ALERTS/ARTICLES
-
Actelion’s Preemptive Strike over REMS and Biostudy Product Availability Draws Antitrust Counterclaims, Another Drug, and Another Company into the Mix
- December 07, 2012
- LEGAL ALERTS/ARTICLES
-
ASBM Says Distinct USAN Names for Biosimilars are Needed
- December 04, 2012
- LEGAL ALERTS/ARTICLES
-
Endo Sues FDA; Seeks Court Orders for FDA Determinations on the Discontinuation of “Old” Opana® ER and With Respect to Approved and Pending ANDAs
- December 04, 2012
- LEGAL ALERTS/ARTICLES
-
Apotex Seeks Exclusivity-Triggering Court Decision in Declaratory Judgment Action Over Generic BENICAR Patent
- November 28, 2012
- LEGAL ALERTS/ARTICLES
-
“Product Hopping” Antitrust Lawsuit Takes on a Heightened Profile with Proposed FTC Amicus Brief
- November 26, 2012
- LEGAL ALERTS/ARTICLES
-
Cumberland Sues FDA after the Agency Denies Citizen Petition and Approves Generic ACETADOTE
- November 16, 2012
- LEGAL ALERTS/ARTICLES
-
With Briefing Over, Post-Mensing Generic Drug Preemption Appeal Awaits Word From the Supreme Court
- November 16, 2012
- LEGAL ALERTS/ARTICLES
-
FDA Presses “Heckler Defense” in Appeal of Unapproved Thiopental Sodium Death Row Inmate Case
- November 13, 2012
- LEGAL ALERTS/ARTICLES
-
Does a Hatch-Waxman Patent Delisting Counterclaim Terminate a 30-Month Litigation Stay?
- November 12, 2012
- LEGAL ALERTS/ARTICLES
-
Excuses, Excuses! A Round-Up of Exceptions under the Failure to Obtain Timely Tentative Approval 180-Day Exclusivity Forfeiture Provision
- November 08, 2012
- LEGAL ALERTS/ARTICLES
-
“New” CDER Exclusivity Board Focuses on Clarity and Consistency of Exclusivity Decisions
- November 08, 2012
- LEGAL ALERTS/ARTICLES
-
Court Orders ANDA Approval in Pre-MMA 180-Day Exclusivity Case; Decision Appears to Have Post-MMA Implications
- October 31, 2012
- LEGAL ALERTS/ARTICLES
-
The End of the Road: Franck’s Compounding Case is Moot
- October 18, 2012
- LEGAL ALERTS/ARTICLES
-
“No-AG” Agreements are Anticompetitive, Says the FTC for a Second Time
- October 18, 2012
- LEGAL ALERTS/ARTICLES
-
Actelion Preemptively Sues Generic Companies Over REMS and Biostudy Product Availability Issues; Case Could be a Bellwether for Future Efforts
- October 11, 2012
- LEGAL ALERTS/ARTICLES
-
Fungal Meningitis Outbreak Prompts Calls for Greater Regulation of Compounders
- October 11, 2012
- LEGAL ALERTS/ARTICLES
-
U.S. Supreme Court is Again Asked to Take Up Drug Patent Settlement Agreements; This Time It’s ANDROGEL
- October 09, 2012
- LEGAL ALERTS/ARTICLES
-
FDA Sued Over Generic DIOVAN 180-Day Exclusivity; Lawsuit Takes Issue With FDA Forfeiture Decision and “Trust Me” Approach to Exclusivity Decisions
- October 05, 2012
- LEGAL ALERTS/ARTICLES
-
New Legislation Would Provide Exclusivity Add-on for Significant Drug Combinations
- October 04, 2012
- LEGAL ALERTS/ARTICLES
-
What’s the Hang-up? Apotex Sues FDA over Compliance Failure That’s Stalling ANDA Approvals
- October 04, 2012
- LEGAL ALERTS/ARTICLES
-
Another Orphan Drug Battle; Depomed Sues FDA over GRALISE Orphan Drug Exclusivity
- September 28, 2012
- LEGAL ALERTS/ARTICLES
-
Legislative Fix Would Allow FDA to Collect GDUFA User Fees
- September 21, 2012
- LEGAL ALERTS/ARTICLES