Business Standard

Tuesday, December 24, 2024 | 07:01 PM ISTEN Hindi

Notification Icon
userprofile IconSearch

Alembic Pharmaceuticals receives USFDA approval for Tadalafil Tablets

Image

Capital Market
Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, of Eli Lilly and Company (Lilly).

All strengths of Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED). Tadalafil Tablet 5mg strength is additionally indicated for treatment of signs and symptoms of benign prostatic hyperplasia (BPH). Alembic had previously received tentative approval for this ANDA.

 

Tadalafil Tablets have an estimated market size of US$ 1.8 billion for twelve months ending December 2018 according to IQVIA.

Powered by Capital Market - Live News

Disclaimer: No Business Standard Journalist was involved in creation of this content

Don't miss the most important news and views of the day. Get them on our Telegram channel

First Published: Mar 27 2019 | 12:13 PM IST

Explore News