Drug Approval | October 02, 2024
Aurobindo Pharma receives USFDA approval for Cephalexin Tablets
The product is expected to be launched in Q3FY25
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
The approval further adds to Biocon’s portfolio of complex drug products
Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
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