Ajanta Pharma Gets CDSCO Panel Nod To Manufacture, Market Tadalafil Oral Jelly for Erectile Dysfunction
New Delhi: Granting the clinical trial study waiver, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod to Ajanta Pharma to manufacture and market Tadalafil Oral jelly 20mg (Orange flavor) for the treatment of erectile dysfunction in adult men.
This came after the firm presented the proposal for manufacturing and marketing of Tadalafil oral jelly 20mg. The firm presented the results of the Bioequivalence study report along with the justification for the clinical trial waiver.
Tadalafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection.
Tadalafil is used to treat erectile dysfunction (ED, impotence; inability to get or keep an erection), and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency in adult men.
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