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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 Ebook.
LEVITRA (vardenafil hydrochloride) tablets,
2.5 mg, are the topic of NDA 021400, held by Bayer HealthCare Pharmaceuticals,
Inc., and initially accepted on August 19, 2003.
LEVITRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. The petitioner has recognized no knowledge or
different information suggesting that LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, have been withdrawn for reasons of
safety or effectiveness. Alembic Pharmaceuticals Limited submitted a
citizen petition obtained on Might 9, 2019 (Docket No. FDA-2019-P-2290),
beneath 21 CFR 10.30, requesting that the Agency determine whether LEVITRA (vardenafil hydrochloride) tablets,
2.5 mg, have been withdrawn from sale for safety or effectiveness
reasons and permit the filing of abbreviated new drug functions (ANDAs) referencing LEVITRA (vardenafil hydrochloride)
tablets, 2.5 mg.