Almebic Pharmaceuticals receives tentative USFDA approval for treatment of erectile dysfunction
DSIJ Intelligence / 04 Jul 2017
Almebic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vardenafil Hydrochloride orally disintegrating tablets, 10 mg.
Almebic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vardenafil Hydrochloride orally disintegrating tablets, 10 mg.
Almebic Pharmaceuticals has a total of 59 ANDA approvals from USFDA. Out of the total approvals from the regulatory board, 52 were final approvals and seven were tentative approvals.
The company’s approved drug is a therapeutically equivalent to the reference listed drug product (RLD) STAXYN of Bayer Healthcare and is used under licence by GlaxoSmithKline Vardenafil Hydrochloride orally disintegrating Tablets indicated for the treatment of erectile dysfunction.
As per IMS,Vardenafil Hydrochloride orally disintegrating tablets had an estimated market size of USD 9.5 million (Rs 61.6 crore) for 12 months ended in December 2016.
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