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Viatris

Viatris, Kindeva win FDA approval for first generic version of Symbicort inhalation aerosol

March 16, 2022 By Sean Whooley

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 the drug-device combination product […]

Filed Under: Business/Financial News, Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance, Respiratory Tagged With: FDA, Kindeva Drug Delivery, Viatris

Prime Therapeutics to prefer Viatris’ interchangeable insulin biosimilar

November 3, 2021 By Sean Whooley

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 with type […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Pharmaceutical Tagged With: biocon, Prime Therapeutics, Viatris

FDA approves insulin glargine biosimilar injection from Viatris, Biocon Biologics

July 29, 2021 By Sean Whooley

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 product is sold […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: biocon, FDA, Viatris

Pfizer agrees to pay $345M in EpiPen pricing lawsuit

July 16, 2021 By Sean Whooley

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 by […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Legal News, Pharmaceutical Tagged With: EpiPen, Mylan, Pfizer, Viatris

Kansas Distric Court rules in favor of Mylan in EpiPen class action

June 24, 2021 By Sean Whooley

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 statute, including claims […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Legal News, Pharmaceutical Tagged With: Mylan, Viatris

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