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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" section of the Orange Guide.
LEVITRA (vardenafil hydrochloride) tablets,
2.5 mg, are the subject of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and initially authorized on August 19, 2003.
LEVITRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for
the remedy of erectile dysfunction. The petitioner
has recognized no data or other information suggesting
that LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, had been withdrawn for reasons of security or
effectiveness. Alembic Pharmaceuticals Restricted submitted a citizen petition obtained on Could 9, 2019 (Docket
No. FDA-2019-P-2290), underneath 21 CFR 10.30, requesting that the Company
decide whether LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg, had been withdrawn from sale for safety or
effectiveness reasons and permit the filing of abbreviated new drug applications (ANDAs) referencing LEVITRA (vardenafil hydrochloride) tablets, 2.5 mg.
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