The FDA has given a thumb's down to an immediate approval of GlaxoSmithKline's experimental nausea therapy Rezonic. Glaxo had been seeking an approval for Rezonic to treat cancer and surgery patients but will now have to proffer additional information before the agency can issue an approval.
There's no word yet over exactly what kind of additional information or data is needed, or if a new trial will be needed to supply it, but Glaxo says that this is just one step on the path to an ultimate approval. The drug giant says it will now study the FDA letter before it moves ahead.
"FDA did not reject our application--rather they issued a complete response letter to indicate the application has been reviewed and specific, additional information is required for the product's approval. That essentially stops the review clock and allows a company to amend the application, then re-start the review process," a spokesperson for the company told Reuters.
If the drug is approved it would be able to compete in a market now dominated by drugs like Merck's Emend and Eisai's Aloxi.
- check out GSK's release
- here's the report from Reuters
- read the AP story