1. Pink Sheet
  2. >>Legal & IP

Legal News: Teva V. FDA, Pay-For-Delay, Citizen Petitions, User Fee Scheme

 
• By Brenda Sandburg

US court tosses Teva suit seeking generic Restasis exclusivity. FTC loses appeal challenging Shire's citizen petitions, settles Solvay pay-for-delay case. DoJ resolves FCA case alleging company made deal to avoid paying FDA user fees for two NDAs.

Courthouse Pillars & Stairs

The pharma industry has had a busy week in court. Perhaps most significantly, a US district court rejected Teva Pharmaceutical Industries Ltd.'s claims that it has the right to 180-day exclusivity for its generic version of Restasis (cyclosporine), noting that FDA has yet to grant even tentative approval to a pending ANDA and it is unknown whether Teva will clear forfeiture hurdles.

In a Feb. 26 order, the US District Court for the District of Columbia granted FDA and intervenor generic...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legal & IP

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 
• By Eliza Slawther

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 
• By Eliza Slawther

The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.

More from Pink Sheet

Industry Criticizes Dutch Decision To Slash PARP Inhibitor Reimbursement

 
• By Francesca Bruce

ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 
• By Bridget Silverman

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.