GEMTESA is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH
Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery
The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA
IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy
The product will be manufactured at Lupin’s Somerset facility in the US
The product is expected to be launched in Q3FY25
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
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