FDA Approves New Generic Vardenafil Hydrochloride Tablets

Officials with the FDA have approved the Abbreviated New Drug Application (ANDA) for Alembic’s Vardenafil Hydrochloride Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. The drug is indicated for the treatment of erectile dysfunction.¹

According to Alembic, the approved ANDA is therapeutically equivalent to Bayer’s vardenafil hydrochloride (Levitra) tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.¹ Vardenafil hydrochloride tablets were developed by GlaxoSmithKline and Bayer, and approved by the FDA in 2003.²

Vardenafil hydrochloride tablet have an estimated market size of $35 billion for 12 months ending June 2020, according to data obtained by Alembic.¹

REFERENCES

• Alembic Pharmaceuticals Receives USFDA Final Approval for Vardenafil Hydrochloride Tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base) [news release]. Vadodara, India; August 5, 2020: Alembic website. https://www.alembicpharmaceuticals.com/wp-content/uploads/2020/08/Press-Release-USFDA-Approval-Vardenafil-Hydrochloride-Tablets-2.5-mg-base-5-mg-base-10-mg-base-and-20-mg-base-August-2020.pdf Accessed August 5, 2020.
• Some Branded Drugs Going Generic in 2018. Markets Insider. https://markets.businessinsider.com/news/stocks/some-branded-drugs-going-generic-in-2018-1013567302# Published January 22, 2018. Accessed August 5, 2020.