Drug Approval | November 20, 2024
Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules
The product will be manufactured at Lupin’s Somerset facility in the US
The product will be manufactured at Lupin’s Somerset facility in the US
Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension
Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
Also received tentative approval for 137 mg
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
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