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

The FDA on Wednes­day not on­ly ap­proved the first gener­ic ver­sions of the decades-old di­a­betes in­sipidus treat­ment va­so­pressin, but al­so si­mul­ta­ne­ous­ly of­fered a par­tic­u­lar­ly damn­ing re­buke of a cit­i­zen pe­ti­tion at­tempt­ing to block the gener­ic, while promis­ing to pass 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 2020 for its brand name ver­sion of the drug Va­sostrict.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.