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U.S. FDA Approved First Generic Viagra for Erectile Dysfunction

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U.S. FDA has given a thumbs up to the Teva Pharmaceutical Industries to market the first generic version of Viagra (sildenafil citrate). The company got the approval to market tablets of 25mg, 50mg, and 100mg strength and 180 days exclusivity.

The quality and strength of the generic drugs approved by the FDA is same as that of brand name drugs. Similar type of the quality standards for manufacturing and packaging are set for the Generic as well as brand name drugs which needs to be cleared.

Sildenafil.svg

Let’s have an insight on how the drug works. When a man is sexually stimulated Nitric Oxide is released from the nerve endings and from the endothelial cells of his spongy erectile tissue, the corpus cavernosum of the penis. Then guanosine triphosphate (GTP) gets converted into cyclic guanosine monophosphate (cGMP) by the enzyme guanylate cyclase. cGMP relaxes the smooth muscles which causes an inflow of blood leading to an erection. Later cGMP hydrolysis back to the inactive GMP by phosphodiesteras type 5 (PDE5)

Here comes the role of sildenafil which works by inhibiting the enzyme PDE5 by occupying its active site leading to late hydrolysis of cGMP which in turn slows down the process of the smooth muscle to relax. Sildenafil is a highly selective inhibitor of PDE5.

Molecular mechanism of sildenafil (figure credit: Lineage Medical, LLC)

 

The generic product will come into the market in December 2017 and it is a prediction that Teva will take good portion out of Pfizer’s blockbuster Viagra.

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