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Teva has become the second generics maker to settle a lawsuit alleging that it conspired with AstraZeneca to delay generic entry of its blockbuster heartburn therapy Nexium, a move that comes as the judge overseeing the case continues to dampen plaintiffs’ antitrust claims. Read More
Mallinckrodt has sued the FDA over its decision last month to revoke the equivalence rating on the company’s generic version of Janssen’s attention deficit hyperactivity disorder drug Concerta. Read More
Manufacturers that adapt existing drugs and biologics to treat rare diseases could receive an additional six months of market exclusivity for the original indication under a new bipartisan House bill. Read More
The FDA’s citizen petition process is overloaded with meritless petitions whose only purpose is to try to delay competition from generic drugs, despite past efforts at reforming it, the agency says. Read More
The FDA has proposed criteria for how an ANDA can receive an expedited review under the “first generic” review prioritization category, a move the agency hopes will ease industry confusion over the generic drug incentive. Read More
The recent spike in generic drug prices is not an isolated phenomenon, says a senator who introduced legislation last month that would require generics firms to provide a rebate to Medicaid if their prices rise faster than inflation, something that brandmakers already are required to do. Read More
In a temporary win for generics manufacturers, the FDA says it will delay its controversial generic drug labeling rule by nine months while it reviews 119 comments it received about the measure. Read More
A federal court decision this fall granting orphan drug marketing exclusivity to Depomed’s post-shingles pain drug Gralise will stand, after the FDA withdrew an appeal filed earlier this month. Read More
Mylan said earlier this month that it has launched a generic version of Warner Chilcott’s oral contraceptive Loestrin 24 Fe in the U.S., following final FDA approval. Read More
The Republican landslide in the midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain. Read More
Biosimilars are expected to account for roughly 4 percent of all biologics sales over the next 10 years, saving the U.S. healthcare system an estimated $44.2 billion, according to new research that forecasts significantly lower savings from the products than another widely cited study. Read More
Citing quality problems at two of Ranbaxy’s Indian manufacturing facilities, the FDA has revoked its tentative approvals for two of the company’s ANDAs, one for a generic of AstraZeneca blockbuster Nexium and the other for Hoffman-LaRoche AIDS drug Valycte. Read More