Drug Approval | September 17, 2025
FDA approves Lupin’s Lenalidomide capsules
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product
Tamsulosin, an alpha-1 adrenergic receptor blocker, combined with Dutasteride, a dual 5- alpha-reductase inhibitor, is indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in adult men
Celecoxib is a nonsteroidal anti-inflammatory drug
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
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