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In a letter dated March 22, 2018, Bayer HealthCare Pharmaceuticals,
Inc., notified FDA that LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, had been being discontinued, and FDA moved
the drug product to the "Discontinued Drug Product List" part of the Orange
Guide. LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg,
are the topic of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and
initially approved on August 19, 2003. LEVITRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile
dysfunction. The petitioner has recognized no information or different info suggesting
that LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, have been withdrawn for causes of security or effectiveness.
Alembic Pharmaceuticals Restricted submitted a citizen petition received on May 9, 2019
(Docket No. FDA-2019-P-2290), beneath 21 CFR 10.30, requesting that the Agency decide whether or not LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg,
have been withdrawn from sale for security or effectiveness reasons and permit the
filing of abbreviated new drug purposes (ANDAs) referencing LEVITRA (vardenafil
hydrochloride) tablets, 2.5 mg.