NEW DELHI, Dec 31:Drug major Glenmark Pharma on Thursday said it has received final approval from the US health regulator for Tadalafil tablets, used to treat erectile dysfunction and enlarged prostate.
The company also received two tentative approvals from the US health regulator.
Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, the company said in a regulatory filing.
The approved product is a generic version of Cialis tablets of Eli Lilly and Company.
Quoting IQVIA sales data for the 12 months ending November 2020, Glenmark said Cialis tablets achieved annual sales of approximately USD 125.5 million.
Glenmark has also received tentative approval from the USFDA for Gabapentin Enacarbil extended release tablets, used to treat moderate-to-severe primary Restless Legs Syndrome (RLS), the company said.
The tentatively approved product is a generic version of Horizant extended-release tablets in the strengths of 300 mg and 600 mg, of Arbor Pharmaceuticals, LLC.
Glenmark said it also received tentative approval for Apremilast tablets in the strengths of 10 mg, 20 mg and 30 mg. Apremilast tablets are used for the treatment of certain types of psoriasis and psoriatic arthritis and is the generic version of Otezla tablets of Amgen, Inc.
Glenmark’s current portfolio consists of 167 products authorised for distribution in the US marketplace and 44 ANDA’s pending approval with the USFDA.
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.
(PTI)
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