PAR STERILE PRODUCTS, LLC et al v. HARGAN et al

  1. September 21, 2018

    Athenex Gets FDA Compounding Policy Wrong, Amicus Says

    Compounder Athenex Pharma Solutions LLC is wrongly attempting to broaden a U.S. Food and Drug Administration policy governing bulk compounding, and its "gross misinterpretation" must be kept out of Par Pharmaceutical's suit challenging that policy, an AmerisourceBergen Corp. subsidiary has told a D.C. federal court.

  2. September 04, 2018

    Court Can't Block Nonfinal Compounding Policy, FDA Says

    Par Pharmaceutical is being premature by asking a D.C. federal court to enjoin a nonfinal policy regarding whether drugs like Par's blood pressure medication vasopressin can be compounded by outside companies, the U.S. Food and Drug Administration told the court.

  3. August 27, 2018

    Par Wants Bulk Vasopressin Compounding Nixed; FDA Agrees

    Just as Par Pharmaceutical asked a D.C. federal court Monday to enjoin a U.S. Food and Drug Administration policy governing bulk drug compounding, the agency agreed the same day that the policy should not apply to Par's blood pressure drug vasopressin. 

  4. August 16, 2018

    Athenex Pharma OK'd To Intervene In Par Suit Against FDA

    A D.C. federal judge has cleared pharmaceutical company Athenex Pharma Solutions LLC to intervene in Par Pharmaceutical's suit accusing the U.S. Food and Drug Administration of improperly letting compounding pharmacies sell cheaper copycats of its blood pressure drug vasopressin.

  5. March 23, 2018

    New FDA Policy Takes Aim At Big Compounders

    The U.S. Food and Drug Administration on Friday moved to limit the operations of large drug compounders, laying out policies that could dramatically curb their ability to sell cheaper versions of FDA-approved products.

  6. January 24, 2018

    FDA, Endo Freeze High-Stakes Drug Compounding Case

    The U.S. Food and Drug Administration and Endo Pharmaceuticals Inc. on Wednesday froze high-stakes litigation over the agency's allegedly unlawful acquiescence to large-scale drug compounding, saying expected policy changes may address the drugmaker's concerns.

  7. October 30, 2017

    Par Pharma Suit Tests FDA's Drug Pricing Pushback

    Efforts by the U.S. Food and Drug Administration to combat dramatic price spikes for prescription drugs are being tested by a new Par Pharmaceutical lawsuit accusing regulators of improperly letting compounding pharmacies sell cheaper copycats, attorneys say.