Teva Xtampza Settlement Brings Potential Three-Year Head Start
Suit In Delaware Court Settled With 2033 Date
Teva is lining up another complex ANDA product after agreeing to settle litigation with Collegium Pharmaceutical over the Israeli firm’s proposed generic version of Xtampza ER (oxycodone) extended-release capsules.
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Teva Still Hopes To Reach Deal On US Price-Fixing Allegations
Teva says it remains hopeful that it can resolve US price-fixing allegations “in a positive way” with the US Department of Justice, but acknowledges that the matter could go all the way to trial.
US FDA Releases Slew Of Guidances On A Fell Day For Complex Generics
New and updated guidances are good news for ANDA sponsors, but timing – coming the day Sandoz announced a CRL for its Advair copy – underscores challenges that developers of complex generics face.
US Supreme Court Reignites Claims Government Overcharged Millions For Generics
In a case that could have significant ramifications for the scope of the US False Claims Act, the US Supreme Court has agreed to remand for further proceedings allegations that supermarket and pharmacy chains defrauded the government via low-cost drug programs.