Alembic Pharma gets USFDA nod to market erectile dysfunction treatment drug

VADODARA (BARODA) | MUMBAI | RAJKOT – In a press release submitted to the Exchanges in India on Tuesday, Alembic Pharma said of having got approval from US Food & Drugs Administration to market erectile dysfunction treatment tablets, the product has an estimated market-size of US $ 8 million over period of 12 months.

Alembic Pharmaceuticals receives USFDA Approval for Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg, the statement read.

Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Orally Disintegrating Tablets, 10mg (base).


DRUG POTENTIAL

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

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 US$ 8 million for twelve 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.


STOCK REACTS

Immediately after the announcement hit the Indian Bourses on Tuesday, a steep temporary upward spike was seen in the share prices of the company, however the interest of investors & traders remained intact and company shares continued trading in GREEN Zone during the trading session on the Indian Exchanges on Tuesday.


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