Viatris (Nasdaq:VTRS) and Kindeva Drug Delivery announced today that the FDA approved its generic version of AstraZeneca’s Symbicort. In March 2021, the FDA granted tentative approval to Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) — the first generic version of Symbicort. Today, the agency granted approval for the abbreviated new drug application (ANDA) for […]
Viatris
Prime Therapeutics to prefer Viatris’ interchangeable insulin biosimilar
Pharmacy benefit manager Prime Therapeutics announced today that it will prefer Viatris’ (NSDQ:VTRS) Semglee insulin biosimilar injection on its national formularies as part of the pharmacy benefit. In July, the FDA cleared the Semglee insulin glargine-yfgn injection, developed by Viatris in collaboration with Biocon Biologics, as a biosimilar for controlling high blood sugar in adults […]
FDA approves insulin glargine biosimilar injection from Viatris, Biocon Biologics
Viatris (NSDQ:VTRS) and Biocon Biologics announced FDA clearance for their Semglee insulin glargine-yfgn injection as a biosimilar. Semglee holds an indication for controlling high blood sugar in adults with type 2 diabetes and pediatric patients with type 1 diabetes. The FDA approved Semglee as the first interchangeable biosimilar product under the 351(k) regulatory pathway. The […]
Pfizer agrees to pay $345M in EpiPen pricing lawsuit
Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices. Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices […]
Kansas Distric Court rules in favor of Mylan in EpiPen class action
Viatris (NSDQ:VTRS) announced that the U.S. District Court for the District of Kansas ruled in favor of Mylan in an EpiPen class action. Mylan, which Pfizer combined with its Upjohn business to form Viatris in November 2020, received a favorable ruling in substantial part that dismissed all of the plaintiffs’ claims under the federal RICO […]
FDA tentatively approves first generic version of Symbicort inhalation aerosol
Viatris (NSDQ:VTRS) and Kindeva Drug Delivery announced today that the FDA granted tentative approval of the first generic version of Symbicort. Symbicort, an inhalation aerosol is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD). The drug had U.S. branded sales of $3.5 billion for the 12 months ended January 2021, according […]
Mylan must face EpiPen racketeering lawsuit
A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device. Drug wholesalers Rochester Drug CoOperative and Dakota Drug filed separate but similar lawsuits in March 2020 and June 2020, respectively, claiming […]
