Alembic Pharmaceuticals gets USFDA final approval for open-angle glaucoma drug
Alembic Pharmaceuticals Limited announced that it has received the final approval from US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Timolol Maleate ophthalmic gel-forming solution, 0.25 per cent and 0.5 per cent.
The above-mentioned drug is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
The company has been granted competitive generic therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved ANDA.
According to IQVIA, this solution has an estimated market size of USD 71 million for twelve-month ending June 2020. This ANDA has been co-developed by Alembic Pharmaceuticals in partnership with Orbicular Pharmaceutical Technologies Pvt Ltd, Hyderabad.
In a separate press release for financial results, the company stated it has six ANDA approvals received during the quarter ended September 2020. Additionally, it had seven ANDA filings during the quarter while cumulative ANDA filings stood at 198.
The stock of Alembic Pharmaceuticals Limited closed at 958.30 today, 1.58 per cent lower than its previous close. The intraday high was 984.05 while its intraday low was 945.20. Since the beginning of the year, the stock has given an absolute return of 72.40 per cent, outperforming the broader market index S&P BSE 500.