 "Glenmark receives US FDA approval for hypertension drug nebivolol")
Glenmark Pharmaceuticals has been granted final approval by the US Food & Drug Administration (FDA) for the hypertension drug nebivolol, for tablets of strengthen 2.5 mg, 5 mg, 10 mg and 20 mg. The approved product is the generic version of Bystolic tablet of Forest Laboratories Llc.
With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for nebivolol tablets. Therefore, with this approval, the company may be eligible for 180 days of generic drug exclusivity for nebivolol tablets.
Nebivolol, which belongs to a group of drugs called beta-blockers, is used to treat hypertension (high blood pressure). By lowering blood pressure, it lowers the risk of a stroke or heart attack.
Under the terms of the prior settlement agreement with Forest, Glenmark will be able to market and distribute its product under a license from Forest three months prior to the expiration of US patent, including any extensions and/or pediatric exclusivity, or earlier under certain circumstances.
According to IMS Health sales data for the 12 month period ending March 2017, the Bystolic tablets (2.5 mg, 5 mg, 10 mg and 20 mg) market achieved annual sales of approximately $ 1 billion.
Glenmark’s current portfolio consists of 116 products authorised for distribution in the US marketplace and approximately 68 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
To read the full story, Subscribe Now at just Rs 249 a month
Already a subscriber? Log in
Subscribe To BS Premium
MONTHLY₹9/day
₹249
Renews automatically
SMART ANNUAL₹5/day
₹1699₹1999
Opt for auto renewal and save Rs. 300 Renews automatically
ANNUAL₹6/day
₹1999
What you get on BS Premium?
-
Unlock 30+ premium stories daily hand-picked by our editors, across devices on browser and app. -
Pick your 5 favourite companies, get a daily email with all news updates on them. '%3E%3Cg id='Artboard-Copy' transform='translate(0 0.012)'%3E%3Cg id='_126115' transform='translate(0 0)'%3E%3Cpath id='Path' d='M17.537 1.487a.473.473 0 0 0-.467.477v12.67A2.4 2.4 0 0 1 14.7 17.06H3.3A2.4 2.4 0 0 1 .933 14.634V.966H14.587v12.29a.467.467 0 0 0 .933 0V.489a.473.473 0 0 0-.467-.477H.467A.473.473 0 0 0 0 .489V14.63a3.346 3.346 0 0 0 3.3 3.382H14.7A3.346 3.346 0 0 0 18 14.63V1.965a.467.467 0 0 0-.462-.478Z' transform='translate(0 -0.012)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-2' d='M12.676 3.955a.478.478 0 1 0 0-.955H2.508a.478.478 0 1 0 0 .955Z' transform='translate(0.124 0.166)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-3' d='M12.676 13H2.508a.478.478 0 1 0 0 .955H12.672a.478.478 0 1 0 0-.955Z' transform='translate(0.124 0.768)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Shape' d='M2 6v5.371a.484.484 0 0 0 .467.5H7.531a.484.484 0 0 0 .467-.5V6a.484.484 0 0 0-.467-.5H2.467A.484.484 0 0 0 2 6Zm.933.5H7.066v4.375H2.933Z' transform='translate(0.122 0.317)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-4' d='M12.321 5.5H8.967a.478.478 0 1 0 0 .955h3.354a.478.478 0 1 0 0-.955Z' transform='translate(0.517 0.317)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-5' d='M12.321 8H8.967a.478.478 0 1 0 0 .955h3.354a.478.478 0 1 0 0-.955Z' transform='translate(0.517 0.467)' fill='%23c4132a'%3E%3C/path%3E%3Cpath id='Path-6' d='M12.788 10.977a.473.473 0 0 0-.467-.477H8.967a.478.478 0 1 0 0 .955h3.354a.471.471 0 0 0 .467-.478Z' transform='translate(0.517 0.617)' fill='%23c4132a'%3E%3C/path%3E%3C/g%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Full access to our intuitive epaper - clip, save, share articles from any device; newspaper archives from 2006.
Preferential invites to Business Standard events.
Curated newsletters on markets, personal finance, policy & politics, start-ups, technology, and more.
Need More Information - write to us at assist@bsmail.in