Vilazodone Hydrochloride tablets are indicated for the therapy of main depressive dysfunction.
“The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Viibryd tablets, 10 mg, 20 mg, and 40 mg, of Allergan Sales,” the drug agency stated.
Citing IQVIA, the corporate stated Hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated market dimension of USD 469 million for 12 months ending September 2019.
Alembic had beforehand acquired tentative approval for this ANDA.
“Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity,” it stated.
The launch of the product will likely be as per settlement settlement with US-based pharmaceutical agency Allergan.
if(geolocation && geolocation != 5 && (typeof skip == 'undefined' || typeof skip.fbevents == 'undefined')) !function(f,b,e,v,n,t,s) (window, document,'script', 'https://connect.facebook.net/en_US/fbevents.js'); fbq('init', '338698809636220'); fbq('track', 'PageView');