Alembic Pharma gets tentative nod from USFDA for ophthalmic solution


PTI | New Delhi | Updated: 09-08-2019 12:53 IST | Created: 09-08-2019 12:53 IST
Alembic Pharma gets tentative nod from USFDA for ophthalmic solution
  • Country:
  • India

Drug firm Alembic Pharmaceuticals on Friday said it has received tentative approval from the US health regulator for Bimatoprost Ophthalmic Solution, indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. The approved product is therapeutically equivalent to the reference listed drug product Lumigan ophthalmic solution 0.01 per cent, of Allergan Inc.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Bimatoprost Ophthalmic Solution 0.01 per cent, Alembic Pharmaceuticals said in a BSE filing. Quoting IQVIA sales data, the company said, Bimatoprost Ophthalmic Solution has an estimated market size of USD 704 million for 12 months, ending December 2018.

The company said it now has a total of 100 ANDA approvals from the USFDA. Shares of Alembic Pharmaceuticals were trading 0.91 per cent higher at Rs 534.75 apiece on BSE.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)

Give Feedback