Home Brand News Alembic Pharmaceuticals receives USFDA Approval for Tadalafil Tablets USP, 2.5 mg, 5...

Alembic Pharmaceuticals receives USFDA Approval for Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg.

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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) 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.
Alembic now has a total of 89 ANDA approvals (77 final approvals and 12 tentative
approvals) from USFDA.

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