Alembic Pharmaceuticals Limited has achieved a significant milestone with the US Food & Drug Administration’s (USFDA) final approval of its Abbreviated New Drug Application (ANDA) for Icatibant Injection, used in the treatment of acute attacks of hereditary angioedema (HAE) in adults. This approval marks the first peptide product approval for Alembic, showcasing their commitment to […]
In a significant development for Glenmark Pharmaceuticals Ltd., the company has received final approval from the United States Food & Drug Administration (U.S. FDA) for its Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5%. This approval positions Glenmark to substantially penetrate a lucrative market segment currently valued at approximately $290 million in annual sales, according […]
Zydus Lifesciences Limited has announced the launch of Mirabegron Extended-Release Tablets, 25 mg, in the US market, following the final approval from the United States Food and Drug Administration (USFDA). This introduction marks Zydus as one of the first suppliers to offer the generic version of this medication, which is primarily used for the treatment […]
Mylan, a global pharmaceutical company, has recently announced the U.S. Food and Drug Administration (FDA) approval of its Estradiol Vaginal Cream USP, 0.01%, a generic version of Allergan’s Estrace. This approval marks a significant addition to Mylan’s comprehensive women’s healthcare offerings, particularly targeting the treatment of vulvar and vaginal atrophy, a condition prevalent among postmenopausal […]