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Last Updated : Nov 20, 2018 11:17 AM IST | Source: Moneycontrol.com

Alembic Pharmaceuticals up 2% on USFDA approval

Vardenafil Hydrochloride Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction. Alembic had previously received tentative approval for this ANDA.

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Share price of Alembic Pharmaceuticals added more than 2 percent intraday Tuesday after company received USFDA approval.

The company has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg (base).

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Staxyn Orally Disintegrating Tablets, 10 mg, of Bayer Healthcare Pharmaceuticals, Inc.

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Vardenafil Hydrochloride Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction. Alembic had previously received tentative approval for this ANDA.

Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg, have an estimated market size of USD 8 million for 12 months ending

December 2017, according to IQVIA.

Alembic now has a total of 78 ANDA approvals (65 final approvals and 13 tentative approvals) from USFDA.

At 11:11 hrs Alembic Pharmaceuticals was quoting at Rs 572.60, up Rs 10, or 1.78 percent.

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First Published on Nov 20, 2018 11:16 am
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