Alembic gets USFDA final nod for glaucoma drug
Alembic gets USFDA final nod for glaucoma drug
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Pharmaceutical major Alembic Pharmaceuticals Limited said that it has received the final approval from US Food & Drug Administration for its abbreviated new drug application Timolol Maleate ophthalmic gel-forming solution, 0.25 pc and 0.5 pc. The company has been gven competitive generic therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved abbreviated new drug application.

As per  IQVIA, this solution has an estimated market size of USD 71 million for one year ending June 2020. This new drug application has been co-developed by Alembic Pharmaceuticals in partnership with Orbicular Pharmaceutical Technologies Pvt Ltd, Hyderabad. In a separate press release for financial results, Alembic Pharmaceuticals stated it has six ANDA approvals received during the quarter ended September 2020. In addition, it had seven ANDA filings during the quarter while cumulative ANDA filings stood at 198.

The stock of Alembic Pharmaceuticals closed at 965 today, 0.90 per cent  lower than its previous close. The intraday high was 984 while its intraday low was 945. Since the beginning of the year, the stock has given an absolute return of 72.40 pc.

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