Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bromfenac Ophthalmic Solution, 0.07%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb Incorporated (Bausch). Bromfenac Ophthalmic Solution 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac Ophthalmic Solution, 0.07% has an estimated market size of US$ 168 million for twelve months ending March 2024 according to IQVIA.Alembic has a cumulative total of 207 ANDA approvals (180 final approvals and 27 tentative approvals) from USFDA.Powered by Capital Market - Live News

Alembic Pharmaceuticals (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivosidenib Tablets, 250 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tibsovo Tablets, 250 mg, of Servier Pharmaceuticals LLC (Servier).Ivosidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: (a) Newly Diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy (b) Adult patients with Relapsed or refractory AML (c) Adult patients with Locally Advanced or Metastatic Cholangiocarcinoma who have been previously treated. Ivosidenib Tablets, 250 mg have an estimated market size of US$ 114 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 207 ANDA approvals (179 final approvals and 28 tentative approvals) from USFDA. Powered by Capital Market - Live News

Alembic Pharmaceuticals has received 11 US Food & Drug Administration (USFDA) Product Approvals (Final & Tentative) during the quarter ended 30 June 2024. The products and indication is summarized as under:Clindamycin Phosphate Topical Gel USP 1%Clindamycin phosphate gel is indicated in the treatment of acne vulgaris.Diazepam Injection USP, 10mg/2mL (5 mg/mL), Single-Dose Prefilled SyringeDiazepam Injection USP Diazepam is indicated for the management of anxiety disorders or for the shortterm relief of the symptoms of anxiety. Selexipag Tablets 1,000mcg and 1,200mcg.Selexipag tablets are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.Binimetinib Tablets 15mgBinimetinib tablet is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.Tretinoin Cream USP, 0.1%,Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris.Sacubitril and Valsartan Tablets, 24mg/26mg, 49mg/51mg, and 97mg/103 mg.Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. It is also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older.Methotrexate Tablets USP, 2.5mgMethotrexate Tablets are indicated for the treatment of neoplastic diseases, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriasis.Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5mg, 75mg, and 150mg.Venlafaxine Hydrochloride Extended-Release Capsules are indicated for the treatment of major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder.Icatibant Injection, 30mg/3 mL (10 mg/mL)Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.Dabigatran Etexilate Capsules, 75mg and 150mgDabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients; treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients.Dabigatran Etexilate Capsules, 110mgDabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients; treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patientsDoxycycline Capsules, 40mg.Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.Bosutinib Tablets, 100mg and 500mgBosutinib tablets are indicated for the treatment of adult patients with a certain type of leukemia called Philadelphia chromosomepositive chronic myelogenous leukemia. Powered by Capital Market - Live News

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for Bosutinib Tablets, 100 mg and 500 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism C.V. (PF Prism). Bosutinib tablets are indicated for the treatment of a certain type of leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia. Bosutinib Tablets, 100 mg and 500 mg have an estimated market size of US$ 275 million for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 206 ANDA approvals (179 final approvals and 27 tentative approvals) from USFDA. Powered by Capital Market - Live News

Alembic Pharmaceuticals announced that the 14th Annual General Meeting (AGM) of the company will be held on 22 July 2024.Powered by Capital Market - Live News