NDAC Puts Hitch In Oxytrol Switch With Negative Self-Selection Vote
This article was originally published in The Tan Sheet
In a 6-5 vote, FDA’s Nonprescription Drugs Advisory Committee said Merck did not show that consumers can appropriately self-select to use Oxytrol for Women in an OTC setting. The company expects to hear from FDA on its Rx-to-OTC switch application by the end of January.
You may also be interested in...
Nonprescription Drugs Advisory Committee member Richard Neill in 2007 praised Merck’s Rx-to-OTC application for Mevacor while voting against the statin switch. On Nov. 9, Merck will try to convince now-chairman Neill and the rest of NDAC that overactive bladder drug Oxytrol can safely be sold OTC.
Prescription asthma drugs on the brink of patent expiry could breathe new life into Rx-to-OTC switches, but not without fierce opposition from some health care providers.
NaZura BioHealth, spun out from Elcelyx Therapeutics, will market its Lovidia weight-loss product in 2014 when it launches into the direct-response channel, before potential suitors get serious about acquiring the brand.