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Liquidia Announces Generic Treprostinil Injection Now Also Available for Subcutaneous Route of Administration


Benzinga | May 24, 2021 04:07PM EDT

Liquidia Announces Generic Treprostinil Injection Now Also Available for Subcutaneous Route of Administration

Liquidia Corporation (NASDAQ:LQDA) ("Liquidia" or the "Company") today announced that Sandoz Treprostinil Injection, a generic form of Remodulin(r), is now also available for subcutaneous ("SC") administration to treat patients diagnosed with pulmonary arterial hypertension ("PAH").

Sandoz Treprostinil Injection was the first fully-substitutable AP rated generic version of Remodulin. Both options for intravenous and SC administration of Sandoz generic Treprostinil Injection are now available at the same specialty pharmacy that dispenses the brand name medicine.

On May 21, 2021, Liquidia PAH's manufacturing partner, Chengdu Shifeng Medical Technologies LTD ("Chengdu") began selling the RG 3ml Medication Cartridge, which may be used to supply medications to PAH patients. Liquidia had previously announced the FDA's clearance of Chengdu's 510(k) supporting the use of the cartridge with the CADD-MS 3 pump manufactured by Smiths Medical, which has been used for the SC administration of Remodulin for more than 10 years.

Scott Moomaw, Liquidia's Senior Vice President of Commercial, said: "We are excited to provide a new option in the parenteral use of Treprostinil Injection. Patients who need and depend on subcutaneously administered treprostinil will now, for the first time, have access to a lower cost generic treprostinil. Through our agreement with Sandoz, we will continue to provide the same level of high-touch support and services to our patients, but at a lower cost compared to the branded product."

Since commercial launch two years ago, Sandoz Treprostinil Injection has only been used for intravenous administration. The cartridges required to operate the CADD-MS 3 pump were not available to patients using generic Treprostinil Injection due to restrictions imposed by other companies. The introduction of the RG 3ml Medication Cartridge has enabled the use of SC administration of Sandoz Treprostinil Injection for the first time.

Keren Haruvi, President, Sandoz Inc. said: "The FDA clearance of a path to bring additional new cartridges required for subcutaneous administration of this medicine means another option for patients who need access to this life-enhancing pulmonary arterial hypertension medicine. Sandoz has a strong track record for manufacturing high-quality generic medicines and supplying them reliably to the patients who need them."

Remodulin(r) (treprostinil) is a registered trademark of United Therapeutics Corporation.

CADD-MS(r) 3 is a registered trademark of Smiths Medical ASD, Inc.






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