Vanda Falls Again As Teva, US FDA Win Judgment In Tasimelteon Approval Case

In its latest legal case, Vanda lost its case against the FDA and Teva over the alleged unlawful approval of the Israeli firm’s generic Hetlioz.

Hand push red Red Cross mark to choose cancellation item , Approve and reject business and document
The court ruled against Vanda in its three challenges of the FDA approval decision. (Shutterstock)

A US district court ruled that the US Food and Drug Administration’s approval of Teva’s generic version of Vanda Pharmaceuticals Hetlioz (tasimelteon) was not unlawful, marking another defeat for the serial litigator.

More from Generics

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

 

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

US FDA’s Speed Of Work Under Trump Quietly Raising Industry Concerns

 

Multiple sources, including former Acting FDA Commissioner Janet Woodcock, told the Pink Sheet that industry is quietly complaining about FDA work delays and they expect the problem will worsen.

Unfreezing US FDA: Generic Drug Officials Make Plea For Public Workshops

 

The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.

Generic Approvals Maintained Pace In December And January, But Is A Slow-Down Coming?

 

Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.

More from Legal & IP

Makary US FDA Nomination Advances, Last Minute Hiccup May Offer Clues On Mifepristone

 

President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.

US FDA May Lose Some Autonomy Under Health Department’s General Counsel Reorg

 

Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.

GLP-1 Compounding: Court Backs US FDA Approach To Managing Drug Shortage List

 
• By 

A lengthy notice-and-comment rulemaking process is not congruent with the congressional mandate to keep an up-to-date list of drugs in short supply, US judge said, denying compounders' request to stay removal of the GLP-1 tirzepatide from the shortage list.