- Pharma
- 1 min read
Endo gains on favorable FDA drug compounding decision
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 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 percent 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.
Endo's shares closed up 2.2 percent at $11.24 on Friday.
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