Drug Approval | May 24, 2025
Zydus receives final approval from USFDA for Isotretinoin Capsules USP
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne
Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older
Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA
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
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