Lupin Limited, a global pharmaceutical major, has seen its share price reach a 52-week high following the launch of its generic Mirabegron Extended-Release Tablets, 50 mg, in the United States. The approval from the United States Food and Drug Administration (USFDA) has enabled Lupin to introduce a generic equivalent of Myrbetriq Extended-Release Tablets, developed by […]
Lupin Limited has secured approval for its abbreviated new drug application (ANDA) for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg from the United States Food and Drug Administration (FDA). The approved product of the Indian pharma company is a generic equivalent of Pfizer’s Toviaz Extended-Release Tablets, 4 mg and 8 mg, which is […]
Zydus Lifesciences (previously Cadila Healthcare) said that its US subsidiary Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) for marketing Mirabegron Extended-Release Tablets USP 25 mg and 50 mg. The product is a generic of Myrbetriq, which has approval for the treatment of overactive bladder (OAB) with symptoms […]
Alembic Pharmaceuticals said that it has secured tentative approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for its generic drug product Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The tentatively approved product is the generic of Pfizer’s Toviaz Extended-Release Tablets, 4 mg and 8 mg. […]
Urovant Sciences has secured global licensing rights from Ion Channel Innovations for the development and commercialization of a promising gene therapy, hMaxi-K. This therapy is currently under development as a potential treatment for patients with overactive bladder (OAB) who have not found relief through traditional oral pharmacologic therapies. This comes at a time when there […]