Zydus launches Mirabegron Extended-Release Tablets in the US
The threat of low-cost competition in the US to Astellas’ Myrbetriq for urinary incontinence has moved a step closer after a court recommended denying an injunction on the launch of generics.
Alkem Lab`s Generic Mirabegro Receives Approval in the U.S.
Astellas just faced a setback in federal court — with a judge invalidating three claims on a patent surrounding an extended release version of its blockbuster overactive bladder drug.
Alkem's Generic Mirabegron Receives Approval in the U.S.
Lupin's Generic Mirabegron Receives Approval in the U.S.
Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients.
As Urovant gears up for the launch of vibegron, its overactive bladder treatment, it is pushing the same drug through the clinic in other indications.
Sawai USA Generic Mirabegron Receives Approval in US