2nd January 2023, India: Alembic Pharmaceuticals Limited (Alembic) announced that it has received US Food & Drug Administration (USFDA) approvals on eight of its Abbreviated New Drug Application (ANDA) in Q3FY24.
The Company has received five final approvals that includes Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg and 1,600 mcg, Dapsone gel, 7.5%, Fluorouracil Injection USP 5g/100mL (50 mg/mL), Pharmacy Bulk Package (Vial), Carmustine for Injection USP 100 mg/vial (Single-dose Vial) and Acyclovir Cream, 5%. The Company has also received three tentative approvals that includes Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, Dapsone gel, 7.5%, Bromfenac Ophthalmic Solution, 0.07%., and Osimertinib Tablets, 40 mg and 80 mg.
Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg and 1,600 mcg with brand name Uptravi Tablets of Actelion Pharmaceuticals US, Inc. the medication is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg with brand name of Xarelto Tablets of Janssen Pharmaceuticals, Inc. Rivaroxaban tablets are indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also used for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), for the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months. These tablets also used for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery and for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding. These tablets also used 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% with brand name of Aczone Gel of Almirall, LLC. 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% with brand name of Prolensa Ophthalmic Solution of Bausch & Lomb Incorporated. 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.
Fluorouracil Injection USP, 5 g/100 mL (50 mg/mL), Pharmacy Bulk Package (Vial) with brand name of Adrucil Injection USP of Pharmcia and Upjohn. Fluorouracil is indicated for the treatment of patients with adenocarcinoma of the colon and rectum, breast, stomach and pancreas.
Carmustine for Injection USP, 100 mg/vial (Single-dose Vial) with brand name of BiCNU Injection of Avet Lifesciences Private Limited. Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. It is used in multiple myeloma in combination with prednisone. It is also used in relapsed or refractory Hodgkin’s lymphoma/Non-Hodgkin’s lymphoma in combination with other approved drugs.
Acyclovir Cream, 5% with brand name of Zovirax Cream of Bausch Health US, LLC. Acyclovir cream, 5% 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 with brand name of Tagrisso Tablets of AstraZeneca Pharmaceuticals LP. 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 L858R mutations, as detected by an FDA-approved test. It is also used in the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
