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The F.C.T contains lactose, therefore its use is not recommended in patients with rare hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

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Therefore, in this final rule, we have modified proposed 428.202(g)(2) to specify that if there are no quarters of the payment amount benchmark period for which a manufacturer has reported units under section 1927(b)(3)(A)(iv) of the Act, and 428.202(d)(3) applies, CMS will use the information determined under 428.202(d)(3) to calculate the benchmark period manufacturer price