The Food and Drug Administration recently sent warning letters to Altaire Pharmaceuticals Inc., Focus Laboratories Inc., and Hub Pharmaceuticals LLC for distributing unapproved new drugs.
Altaire Pharmaceuticals and Focus Laboratories both distribute FreshKote sterile ophthalmic solution as a prescription drug for the prevention of dry eye. Hub Pharmaceuticals distributes the diagnostic aid fluorescein injection.
FDA said in the letters that there are no FDA-approved applications on file for these drugs. “Distributing these products or any other new drugs without approved applications” is a violation, the agency told the companies.
Enforcement Action.
The agency said it will not initiate ...
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