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Takeda is ending all trials of its type 2 diabetes drug fasiglifam after determining that the drug’s benefits were outweighed by liver risks. Read More
Generics makers should design tablets and capsules to be similar in size and shape to their reference listed drug (RLD) when they seek ANDA approval, the FDA says. Read More
A group of generic drugmakers is proposing the FDA take the lead on initiating drug labeling changes prompted by adverse events, rather than relying on individual companies to initiate the changes. Read More
The FDA plans to standardize electronic drug applications and other regulatory submissions over the next five years and will release a host of guidances in 2014 and 2015 to implement the standardization. Read More
French authorities have fined Merck $21.5 million for its efforts to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More
U.S. lawmakers Dec. 11 introduced a bill that would prohibit patent litigation settlements in which a brand drugmaker compensates a generic drugmaker to delay sales of a competing generic drug, commonly referred to as “pay-for-delay” deals. Read More
The generics industry enters uncharted territory in 2014 as it adjusts to a landscape altered by monumental Supreme Court rulings in 2013 and the FDA’s proposed rule to authorize generic drugmakers, for the first time, to change product labeling in response to safety signals. Here’s an overview of the significant events that happened in 2013 and how they promise to shape the industry in 2014 and beyond. Read More
Hot on the heels of Amgen’s state-level campaign to limit dispensation of biosimilars, the biotech is voicing strong opposition to plans by the FDA to allow biosimilars to share the same international non-proprietary name (INN) as the biologic they reference, calling for unique INNs. Read More
HHS has approved the overhaul of the FDA’s Office of Generic Drugs (OGD), allowing the agency to move most of its functions relating to generic drugs under one roof. Read More