FDA Law Blog
AUGUST 21, 2023
Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false. But we digress.
FDA Law Blog
APRIL 7, 2025
Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. The allegations in the Warning Letters are serious, but thats not why theyre so interesting.
FDA Law Blog
SEPTEMBER 14, 2021
The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.
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