FDA Approves First Generic Version of ED Drug
Teva has been granted approval to market generic Sildenafil Citrate Tablets with 180-day exclusivity. Generic drugs have the same quality and strength as brand-name drugs. For FDA approval, generic manufacturing and packaging sites must pass the same quality standards as brand-name drugs.
Sildenafil enhances the effect of nitric oxide by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. It has no direct relaxant effect on isolated human corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum.
Teva's Sildenafil Citrate Tablets will be available as 25mg, 50mg, and 100mg strengths.