Merck & Co. Inc. and development partner Samsung Bioepis Co. Ltd. could bring the second copy of Sanofi's blockbuster long-acting insulin Lantus (insulin glargine) to the US market now that the product has been tentatively approved by FDA. Merck announced the tentative approval of Lusduna Nexvue July 20, setting the company up to launch the drug following the resolution of ongoing patent litigation.
FDA's tentative approval designation means a drug has met the regulatory standards for approval, but it is subject to an...
