The agency’s decision renders the sale of compounded products containing vasopressin, a BP treatment unlawful unless manufactured using an FDA-approved product, Endo said.
U.S: Endo International Plc said on Friday the U.S. health regulator has decided not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved version of the product.
The company had sued the Food and Drug Administration in October 2017, alleging that the agency had improperly authorized the bulk compounding of hundreds of drugs, including “essentially a copy” of Endo’s Vasostrict.
The agency’s decision renders the sale of compounded products containing vasopressin unlawful unless manufactured using an FDA-approved product, Endo said.
Endo subsidiary Par Sterile Products LLC makes Vasostrict, the only vasopressin product approved by the FDA.
Vasostrict accounted for about 15.4 per cent of Endo’s total sales in 2018.
Compounding is a practice in which a licensed pharmacist, physician, or outsourcing facility uses the chemical ingredients of a drug to create a medication tailored to the needs of an individual patient.