Business
Liquidia Announces Generic Treprostinil Injection Will Be Available for Subcutaneous Route of Administration
Addressable market for generic Treprostinil Injection more than doublesFDA cleared 510(k) for RG 3ml Medication Cartridge for use with CADD-MS® 3 pump
About this update from Liquidia Corporation
[{"type":"text","content":"Addressable market for generic Treprostinil Injection more than doublesFDA cleared 510(k) for RG 3ml Medication Cartridge for use with CADD-MS® 3 pump RESEARCH TRIANGLE PARK, N.C., March 30, 2021 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”) today announced that Treprostinil Injection, a generic form of Remodulin®, will soon be available for subcutaneous (“SC”) administration to treat patients diagnosed with pulmonary arterial hypertension (“PAH”). On March 26, 2021, the U.S. Food and Drug Administration (“FDA”) cleared the 510(k) application submitted by Liquidia PAH’s manufacturing partner, Chengdu Shifeng Medical Technologies LTD (“Chengdu”) for the RG 3ml Medication Cartridge which is indicated for use with the CADD-MS 3 pump. Manufactured by Smiths Medical, the CADD-MS 3 pump has been used for the SC administration of Remodulin for more than 10 years. Damian deGoa, Liquidia’s Chief Executive Officer, said: “We are very thankful for the effort and support Chengdu has demonstrated to enable the subcutaneous administration of Treprostinil Injection. We worked hard to overcome this obstacle, and we can now offer generic Treprostinil Injection to more than double the number of PAH patients. We will continue to offer patients, prescribers and payers the same high-touch services and support but at a lower cost compared to the branded product.” Since commercial launch two years ago, Treprostinil Injection has only been used for intravenous administration. The cartridges required to operate the only subcutaneous pump that could deliver treprostinil injection (CADD-MS 3) were not made available to patients using generic treprostinil injection. The introduction of the RG 3ml Medication Cartridge will enable the launch of SC administration of Treprostinil Injection for the first time. Remodulin® (treprostinil) is a registered trademark of United Therapeutics Corporation.CADD-MS® 3 is a registered trademark of Smiths Medical ASD, Inc. About Treprostinil InjectionTreprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration. Treprostinil Injection contains the same active ingredient, same strengths, same dosage form and same inactive ingredients as Remodulin® (treprostinil), and is offered to patients and physicians with the same level of servic...