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(iii) The manufacturer is not a first applicant during the 180-day exclusivity period, as those terms are defined in section 505(j)(5)(B)(iv) of the FD&C Act

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As the first step in the reporting process, as set forth in 427.501(b) and consistent with section 60 of the revised Medicare Part B Drug Inflation Rebate Guidance, we will provide the manufacturer of a Part B rebatable drug with the preliminary rebate amount through a Preliminary Rebate Report that is provided to each manufacturer of a Part B rebatable drug at least 1 month prior to the issuance of the Rebate Report as set forth in 427.501(c) for an applicable calendar quarter (that is, not more than 5 months after the end of the ( applicable calendar quarter)

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"I started having fatigue, and then started getting weak in my limbs and my legs," Welborn said