Merck (NYSE:MRK) said today that the FDA granted tentative approval for its Lusduna Nexvue insulin glargine injection.
The biologic basal insulin met regulatory standards, the company said, but a patent infringement lawsuit initiated by competitor Sanofi (NYSE:SNY) in September of last year invoked an automatic delay for the drug-device combination product’s final approval.
The stay could last up to to 30 months, according to the Hatch-Waxman Act. If a court rules in favor of Merck before that period ends, the product can hit the market.
“The tentative approval of Lusduna Nexvue is an important milestone, bringing us closer to offering this medicine to patients,” Dr. Sam Engel, associate VP of clinical research, for Merck’s diabetes, endocrinology & women’s health businesses, said in prepared remarks.
