In the wake of a favorable US Court of Appeals for the Federal Circuit decision, Viatris has won FDA approval for the first generic Symbicort product. The ANDA sponsor’s management had recently declared itself “ready to launch if the opportunity presents itself in 2022.”
Viatris had declared only days ago that it was not anticipating introducing its proposed generic version of AstraZeneca’s Symbicort (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler until 2023.
This may change, however, after the company on 15 March scooped the first US Food and Drug Administration approval for an ANDA product referencing the respiratory blockbuster –
A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.
Teva underlined that it was “very pleased with this franchise we’re building and what we’ll bring to the care of patients with schizophrenia,” as it looks ahead to filing its olanzapine new drug application in the second half of 2025.
Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.
