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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In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.
Data on the number of ANDAs submitted with valid paragraph IV certifications shows some products with strong generic interest and others with almost none.
US FDA Commissioner Gottlieb says common diseases need new treatments and argues streamlining trials may pique industry interest.