FDA's effort to focus on expediting generic approvals is not extending to complex generics, according to Mylan NV.
President Rajiv Malik said during Mylan's Aug. 9 second quarter earnings call the agency has focused on accelerating approval of...
Company says that while FDA has focused on expediting approval of third and fourth generics, it has not done so for first generics and complex products.
FDA's effort to focus on expediting generic approvals is not extending to complex generics, according to Mylan NV.
President Rajiv Malik said during Mylan's Aug. 9 second quarter earnings call the agency has focused on accelerating approval of...
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.