A generic form of Remodulin is available for to treat pulmonary arterial hypertension (PAH) subcutaneously, thanks to a new medication cartridge.
The new cartridge became available May 21. The U.S. Food and Drug Administration approved generic treprostinil injection for intravenous and subcutaneous PAH treatment in 2019. However, manufacturer restrictions on medication pump cartridges limited the generic’s use to only intravenous delivery. See our 2019 story.
The injection contains the same active ingredient, strength, dosage form and inactive ingredients as Remodulin, as required by the FDA. Both the intravenous and subcutaneous versions are available from the same specialty pharmacy that dispenses the brand name medicine.
The new medication cartridge is the result of a partnership between pharmaceutical company Liquidia and Santoz, which holds FDA approval for the treprostinil injection.
“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,” Keren Haruvi, president of Sandoz, said in the news release.
Learn about financial assistance options for PAH therapies or call the Pulmonary Hypertension Association at 301-565-3004 x758.