Alembic Pharmaceuticals received various US Food & Drug Administration (USFDA) product approvals (Tentative or Final) during the quarter ended 31st December, 2023. Alembic has a cumulative total of 196 ANDA approvals (170 final approvals and 26 tentative approvals) from USFDA. VTE), in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI) and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD)., Dapsone gel, 7.5%, Final, Almirall, LLC, Aczone Gel, Dapsone gel,7.5% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older., Bromfenac Ophthalmic Solution, 0.07%., tentative, Bausch & Lomb Incorporated., Prolensa Ophthalmic Solution, Bromfenac ophthalmic solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Product Name, Approval Final/Tentative, Innovator Name, Brand name, Indication, Fluorouracil Injection USP, 5 g/100 mL (50 mg/mL), Pharmacy Bulk Package (Vial)., Final, Pharmcia and Upjohn, Adrucil Injection USP, Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with-, - Adenocarcinoma of the Colon and rectum, - Adenocarcinomaof the Breast, Gastric, Adenocarcinoma, Pancreatic, Adenocarcinomas, Carmustine for Injection USP, 100 mg/vial (Single-dose Vial)., Avet Lifesciences Private Limited, BiCNU Injection, Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors., Multiple myeloma in combination with prednisone., Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs., Relapsed or refractories Non-Hodgkin's lymphomas in combination with other approved drugs. Refer label for full indication. Product Name, Approval final/Tentative, Innovator name, Indication, Acyclovir Cream, Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor 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., tentative, AstraZeneca Pharmaceuti cals LP, Tagrisso Tablets, Osimertinib tablets are indicated for -the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21.