Resources for Food and Drug Administration (FDA)
Alcon shelves study for eye drug Retaane for wet AMD after FDA approvable letter
money.cnn.com Alcon said the US Food and Drug Administration has issued an approvable letter for its eye drug Retaane for the treatment of wet age-related retinal deterioration (AMD).
The letter advised Alcon that approval will require an additional clinical study, the US eyecare group, which is majority owned by Nestle SA, said in a statement.
It said it has no immediate plans to conduct a new study of Retaane for this indication due to the difficulty of recruiting patients.
The FDA issues an approvable letter in cases where it is prepared to authorise a treatment pending the resolution of 'minor deficiencies'.
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