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Facing a drastic loss of revenue and market share to a competing generic drug, Indivior said it will appeal an adverse federal court ruling on its patent for Suboxone (buprenorphine and naloxone), a sublingual film indicated for the maintenance treatment of opioid dependence. Read More
An FDA policy proposal on expedited generic drug approvals runs counter to the goals of the program and breaks faith with the upcoming GDUFA II agreement with the industry, generic drugmakers said. Read More
As part of a broad effort to increase competition and lower drug prices, the FDA spelled out what it expects from ANDA sponsors seeking earlier meetings to smooth out the review process. Read More
Following the launch of GDUFA II Oct. 1, the FDA released final guidances and timelines for reviewing generic prior approval supplements and API drug master files. Read More
The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read More
To curb abuse of the Hatch-Waxman system, the FDA should consider allowing generic drug manufacturers to create their own REMS, according to CVS Health. Read More
Sen. Claire McCaskill (D-Mo.) introduced legislation that would bar patent arrangements like the controversial deal between Allergan and a Native American tribe. Read More
The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described as unfair, ambiguous and impractical. Read More
The FDA is streamlining its communications with generics manufacturers, and outlined its procedures for relaying the status of an ANDA review in a new manual for staff. Read More