April 1 (Reuters) - Eli Lilly ( LLY ) said on Tuesday it
had sued two mass compounders for selling unapproved products
that contain tirzepatide, the main ingredient in its popular
weight-loss and diabetes medicines.
This comes after a U.S. federal judge last month refused to
allow compounding pharmacies to keep making copies of these
drugs in the United States.
Compounders had been allowed to produce hundreds of
thousands of doses of copies of obesity drugs only while the FDA
said there was a shortage of them.
Lilly has already sued more than two dozen medical spas,
wellness centers and compounding pharmacies for selling products
claiming to contain tirzepatide.
The new lawsuits from Lilly name Strive Pharmacy LLC and
Empower Clinic Services LLC. Lilly said the companies were
selling unapproved drugs and making false claims about efficacy
and safety.
Lilly said Strive's tirzepatide products, which come in
standard doses added with vitamin B12 or glycine, are falsely
suggested to be safer and more effective than FDA-approved
medicines.
Empower offers compounded tirzepatide as an oral pill and an
injectable version with a form of vitamin B3 added to it,
falsely suggesting their efficacy by citing Lilly's own clinical
studies, according to Lilly.
The complaint against Empower was filed in the district
court of New Jersey and the one against Strive was filed in the
district court of Delaware.
The drugmaker will also send about fifty cease and desist
letters to compounders and telehealth companies, asking them to
confirm that they have already ceased mass compounding.
(Reporting by Christy Santhosh in Bengaluru; Editing by
Saumyadeb Chakrabarty)