4th July 2023 Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received US Food & Drug Administration (USFDA) approvals on 5 of its Abbreviated New Drug Application (ANDA) in Q1 of FY 23-24. The Company has received 4 final approvals that includes Bepotastine Besilate Ophthalmic Solution, 1.5%, Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg, Carboprost Tromethamine Injection USP, 250 mcg/mL Single-Dose Vials, Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multiple-Dose Vials. Besides these, the Company has received one tentative USFDA approval for Doxycycline Capsules, 40 mg.
Summarised Product Approval received during the quarter ended 30th June, 2023.
| Product Name | Approval Final/ Tentative |
Innovator Name | Brand name | Indication* |
| Bepotastine Besilate Ophthalmic Solution, 1.5%. | Final | Bausch & Lomb Incorporated | Bepreve Ophthalmic Solution | Bepotastine besilate ophthalmic solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. |
| Doxycycline Capsules, 40 mg, | Tentative | Galderma Laboratories, L.P. | Oracea Capsules | Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea. |
| Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg. | Final | USWM, LLC | Corgard Tablets | Nadolol tablets are indicated for the long-term management of patients with angina pectoris and for the treatment of hypertension, to lower blood pressure. |
| Carboprost Tromethamine Injection USP, 250 mcg/mL Single-Dose Vials. | Final | Pfizer, Inc. | Hemabate Injection | Carboprost tromethamine injection, USP sterile solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation. It is also indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. |
| Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multiple-Dose Vials. | Final | Genzyme Corporation | Hectorol Injection | Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis |
Alembic has received a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.