Epoprostenol Sodium

DUBLIN, April 22, 2024 /PRNewswire/ -- Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is expanding its voluntary recall to include seven lots of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution. Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Par has not received any reports of adverse events related to this recall. Treprostinil Injection is formulated for subcutaneous or intravenous infusion. The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from epoprostenol to reduce the rate of clinical deterioration. Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. The following lots are affected by this recall: The lots were distributed nationwide to wholesalers and hospitals from June 16, 2022 through August 7, 2023. See labels of vials from the affected lots here. Par is providing written notification to wholesale accounts and the hospital location that have received the affected lot and is arranging for return of all existing inventory through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product. For information regarding the recall process, call Inmar, Inc. at 1-855-410-3565 Monday through Friday between the hours of 9 am and 5 pm EST. For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, statements with respect to the voluntary recall of Treprostinil Injection, the reasons for and the risks associated with the recall, the potential for adverse events and adverse event reporting, communications with and responses from regulators, and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "outlook," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of risk factors. Additional information concerning risk factors can be found in press releases issued by the Company, as well as public periodic filings with the U.S. Securities and Exchange Commission (the "SEC") and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K. SOURCE Endo International plc

After two federal court decisions last week, Liquidia Corporation says that the FDA is cleared to approve its pulmonary arterial hypertension inhaler Yutrepia, a potential rival to United Therapeutics' blockbuster Tyvaso. With one injunction lifted and another denied late last week in lawsuits filed by United Therapeutics, rival Liquidia Corporation says the FDA has clearance to approve its pulmonary arterial hypertension (PAH) treatment Yutrepia. Thursday in U.S. District Court in Delaware, in United’s original patent case against Liquidia, Judge Richard Andrews removed an injunction that had prohibited the FDA from approving Yutrepia. United has appealed the decision. A day later, in federal court in Washington, D.C., Judge John Bates denied a motion for a temporary restraining order in litigation filed by United against the FDA. The decisions came shortly before the expiration on Sunday of United’s regulatory exclusivity for its PAH blockbuster Tyvaso (treprostinil) to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). The developments could spell the end of the short reign of exclusivity for United’s successful dry powder inhaler (DPI) formulation of the drug. The new version of Tyvaso was approved in May of 2022 and accounted for 59% ($731 million) of the franchise's sales of $1.23 billion last year. Tyvaso DPI sparked United to a company record of $2.33 billion in revenue in 2023, a 20% increase from 2022. The FDA accepted Liquidia’s application for a dry powder version of treprostinil in 2020 and then rejected it with a complete response letter seven months later. A year later, the FDA granted tentative approval to Yutrepia. Last year, the FDA accepted Liquidia’s amendment to the filing which sought the addition of a second indication, pulmonary hypertension associated with interstitial lung disease (PH-ILD). That prompted United to sue the FDA, claiming that the regulator allowed Liquidia to sidestep “rules, precedents and procedures” in accepting the amendment. United contended that the FDA should have required Liquidia to submit an entirely separate application to treat PH-ILD. “Our commercial team is fully prepared to launch Yutrepia in both PAH and PH-ILD should the FDA grant final approval," Roger Jeffs, CEO of Liquidia, said in a release. "Once launched, we are confident that Yutrepia’s convenient, low-effort delivery and wide dosing range will propel the therapy towards our goal of establishing Yutrepia as the prostacyclin of first choice.” United did not respond immediately to a request for comment. The company has filed an additional lawsuit against Liquidia in federal court in Delaware alleging that Yutrepia would infringe a patent that was issued in November of last year. United has filed for another preliminary injunction in that case which would prevent Liquidia from launching Yutrepia for PH-ILD.