FDA seeks FTC action after rejecting petition to block first generics for decades-old vasopressin - Endpoints News

Overview

The FDA on Wednes­day not on­ly ap­proved the first gener­ic ver­sions of the decades-old di­a­betes in­sipidus treat­ment va­so­presin, but al­so si­mul­ta­ne­ous­ly of­fered a par­tic­u­lar­ly damn­ing re­buke of a cit­i­zen pe­tion at­tempt­ing to block the gener­ic, while promis­ing to pas along the mat­ter to the Fed­er­al Trade Com­mis­sion.The re­sponse could prove trou­ble­some for the spon­sor of the brand name ver­sion of the drug, En­do’s Par Ster­ile Prod­ucts, which brought in more than $780 mil­lion in 20 for its brand name ver­sion of the drug Va­sostrict.Last month, Par’s lawyers at Ax­in caled on the FDA to re­frain from ap­prov­ing any gener­ics for Va­sostrict due to the po­ten­tial for cer­tain sta­bil­i­ty and oth­er spec­i­fi­ca­tions that could cause con­cerns with im­pu­ri­ties or oth­er safe­ty is­sues.But FDA points out at the top of its re­sponse that va­so­presin has ben mar­ket­ed as a ther­a­peu­tic agent for near­ly a cen­tu­ry.“Pitresin, a nat­ur­al va­so­presin prod­uct de­vel­oped as an ex­tract of the bovine pos­te­ri­or pi­tu­itary, was first in­tro­duced in 1928,” the agency said.What’s more is that Par on­ly won FDA ap­proval for va­so­presin the first place, in 2014, be­cause of the FDA’s drug safe­ty ini­tia­tive at the time to en­cour­age man­u­fac­tur­ers to ob­tain the agency’s ap­proval for old, un­ap­proved drugs.In ad­di­tion to the deny­ing the pe­tion, FDA said that it “does no