Zydus erectile dysfunction drug Avanafil to be sold only on Cardiologists, Psychiatrists, Urologists prescription: CDSCO panel

The approval came after the drugmaker presented the Phase-III Clinical trial report and BE study report with a proposal for grant of permission to manufacture and market the drug Avanafil Tablets in three different strengths including 50 mg, 100mg, 200mg.

Avanafil is in a class of drugs called phosphodiesterase inhibitors that also includes tadalafil (Cialis), sildenafil (Viagra), and vardenafil (Levitra). Brand named Stendra, Avanafil is a medication prescribed for the treatment of impotence (erectile dysfunction) in men.

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Avanafil is already approved in other countries like the USA and European Union. On April 27, 2012, the U. S Food and Drug Administration (USFDA) gave its nod to the formulation while the European Medicines Agency (EMA) approved it on June 21, 2013.

It was invented at Mitsubishi Tanabe Pharma, formerly known as Tanabe Seiyaku Co., and licensed to Vivus Inc., which partnered with Menarini Group to commercialize Spedra in over forty European countries, Australia, and New Zealand. Metuchen Pharmaceuticals obtained exclusive rights within the United States.

Now, Indian drugmaker, Zydus Healthcare submitted its proposal for the formulation with the CDSCO Committee. Accordingly, after detailed deliberation,

"The committee recommended for grant of permission to manufacture and market the drug in the country with condition that the drug should be sold by retail on the prescription of Cardiologists/ Psychiatrists/ Urologists only."

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