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Alembic Pharmaceuticals Gets USFDA Approvals For Eight Drug Applications

The approvals include five final approvals for medications such as Selexipag Tablets (multiple strengths), Dapsone gel (7.5 per cent), Fluorouracil Injection USP 5g/100mL (50 mg/mL), Carmustine for Injection USP 100 mg/vial, and Acyclovir Cream (5 per cent)

Alembic Pharmaceuticals has proudly announced the receipt of approvals from the US Food & Drug Administration (USFDA) for eight of its Abbreviated New Drug Applications (ANDA) during the third quarter of the fiscal year 2024.

The approvals include five final approvals for medications such as Selexipag Tablets (multiple strengths), Dapsone gel (7.5 per cent), Fluorouracil Injection USP 5g/100mL (50 mg/mL), Carmustine for Injection USP 100 mg/vial, and Acyclovir Cream (5 per cent). Additionally, the company received three tentative approvals for Rivaroxaban Tablets USP, Dapsone gel (7.5 per cent), Bromfenac Ophthalmic Solution (0.07 per cent), and Osimertinib Tablets (40 mg and 80 mg).

Selexipag Tablets, known as Uptravi Tablets under Actelion Pharmaceuticals US, Inc., are indicated for the treatment of pulmonary arterial hypertension (PAH), with a focus on delaying disease progression and reducing the risk of hospitalization for PAH.

Rivaroxaban Tablets, branded as Xarelto Tablets by Janssen Pharmaceuticals, Inc., serve multiple purposes including reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treating deep vein thrombosis (DVT) and pulmonary embolism (PE), and prophylaxis for various conditions.

Dapsone gel, recognised as Aczone Gel from Almirall, LLC, is designed for the topical treatment of acne vulgaris in patients 12 years of age and older.

Bromfenac Ophthalmic Solution (0.07 per cent), marketed as Prolensa Ophthalmic Solution by Bausch and Lomb Incorporated, is indicated for the treatment of postoperative inflammation and reduction of ocular pain post cataract surgery.

Fluorouracil Injection USP (5 g/100 mL), known as Adrucil Injection USP from Pharmcia and Upjohn, is approved for the treatment of adenocarcinoma in various organs, including the colon, rectum, breast, stomach, and pancreas.

Carmustine for Injection USP (100 mg/vial), branded as BiCNU Injection by Avet Lifesciences , finds application in palliative therapy for brain tumours, multiple myeloma, and relapsed or refractory Hodgkin's lymphoma/Non-Hodgkin’s lymphoma.

Acyclovir Cream (5 per cent), with the brand name Zovirax Cream from Bausch Health US, LLC, is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.

Osimertinib Tablets (40 mg and 80 mg), recognised as Tagrisso Tablets from AstraZeneca Pharmaceuticals LP, are approved for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations.



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