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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, were being discontinued, and FDA moved the
drug product to the "Discontinued Drug Product List" part
of the Orange E-book. LEVITRA (vardenafil hydrochloride) tablets, 2.5
mg, are the topic of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and initially authorised on August 19, 2003.
LEVITRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the
therapy of erectile dysfunction. The petitioner has identified no data or different information suggesting that LEVITRA
(vardenafil hydrochloride) tablets, 2.5 mg, have been withdrawn for reasons of security or effectiveness.
Alembic Pharmaceuticals Restricted submitted a citizen petition received on Might
9, 2019 (Docket No. FDA-2019-P-2290), beneath 21 CFR 10.30, requesting that the Company decide whether or not LEVITRA (vardenafil hydrochloride) tablets, 2.5
mg, were withdrawn from sale for security or effectiveness causes and permit the filing of abbreviated new drug functions
(ANDAs) referencing LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg.