Eli Lilly’s request to intervene in a suit filed by compounding pharmacies against the FDA reflects a belief the outcome could affect its business and that the FDA does not adequately represent its interests.
The FDA has approved Lilly's Zepbound, a glp-1 agonist, for the treatment of sleep apnea, which affects 25 million Americans and is often treated with a CPAP machine, but is often declined due to its cumbersome nature.
Eli Lilly is joining in a lawsuit filed by the Outsourcing Facilities against the FDA, aiming to reverse the FDA's October 2024 determination that the shortage has been resolved, which would allow compounding pharmacies to continue selling unapproved versions of the drugs, according to court documents obtained by Becker's .
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and
The Food and Drug Administration approved Eli Lilly’s weight-loss drug Zepbound on Dec. 27 to treat sleep apnea, a common but potentially serious sleep-related breathing disorder, making it the first medication for certain patients with the condition.
Eli Lilly has asked to join in opposing a lawsuit brought by compounding pharmacies against the U.S. Food and Drug Administration over the agency's decision that Lilly's blockbuster weight-loss and diabetes drugs are no longer in short supply.
Eli Lilly seeks to defend its interests in a lawsuit challenging the FDA's decision on the supply status of its drugs Zepbound and Mounjaro. The lawsuit, filed by compounding pharmacies, aims to reverse the FDA's determination that these drugs are no longer in short supply.
Eli Lilly (LLY) is reportedly seeking to oppose a lawsuit filed by compounding pharmacies over the FDA's determination that its weight-loss drugs are no longer in short supply.
In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies to produce Victoza, also known as liraglutide, following a proposal by the trade group the Outsourcing Facilities Association (OFA) to add the molecule to its compounding roster.
The FDA has approved Lilly's Zepbound, a glp-1 agonist, for the treatment of sleep apnea, which affects 25 million Americans and is often treated with a CPAP machine, but is often declined due to its cumbersome nature.
Novo Nordisk (NOVO) is petitioning the FDA to exclude its diabetes drug liraglutide, also known as Victoza, from a list of drugs that are allowed to be compounded. In a Citizen Petition posted on Regulations.