FDA's Off-Patent, Off-Exclusivity List Draws Few Takers Early On
US agency has received 'very few' inquiries about the drugs on the list since its release.
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Data suggests fewer approvals and new product ideas, as the business case for new generic and brand treatments seems to be tougher to make now than at other times during the pandemic.
The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.
Office of Generic Drugs official says the FDA may be able to harmonize its requirements with regulators who do not have a blanket mandate.