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.

Last month, Par’s lawyers at Ax­inn called 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 va­so­pressin has been mar­ket­ed as a ther­a­peu­tic agent for near­ly a cen­tu­ry.

“Pitressin, a nat­ur­al va­so­pressin 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 va­so­pressin in 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 pe­ti­tion, FDA said that it “does not on its face raise valid sci­en­tif­ic or reg­u­la­to­ry is­sues” and “it ap­pears to have been sub­mit­ted with the pri­ma­ry pur­pose of de­lay­ing ap­proval of Ea­gle’s AN­DA and fails to raise valid sci­en­tif­ic or reg­u­la­to­ry is­sues. The Agency in­tends to re­fer this mat­ter to the Fed­er­al Trade Com­mis­sion (FTC), which has the ad­min­is­tra­tive tools and the ex­per­tise to in­ves­ti­gate and ad­dress an­ti­com­pet­i­tive busi­ness prac­tices.”

This kind of ac­tion from the FDA is rare to see, as lawyer Kurt Karst at Hy­man, Phelps & Mc­Na­ma­ra not­ed on Twit­ter, and it may be part of a wider col­lab­o­ra­tion be­tween the FDA and FTC to put com­pa­nies on no­tice over at­tempts to block fu­ture gener­ics.

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”