The FDA has sent Allergan a warning letter relating to misleading information printed in a professional journal advertisement for its ophthalmic solution, Acular LS.
The FDA has sent Allergan a warning letter relating to misleading information printed in a professional journal advertisement for its ophthalmic solution, Acular LS.
The FDA remonstrated Allergan for printing information that broadens the product's indication, presents unsubstantiated superiority claims and omits important risk information for Acular LS.
Acular LS, according to the FDA approved product labelling, is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.