Drug Approval | August 28, 2024
Zydus receives USFDA final approval for Amantadine ER capsules 68.5 mg
Also received tentative approval for 137 mg
Also received tentative approval for 137 mg
Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission
Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis
Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace
The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms
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