Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, has introduced paricalcitol injection, a generic version of AbbVie's Zemplar. Hospira obtained US Food and Drug Administration (FDA) approval of paricalcitol on October 21 and launched the product November 1.
Hospira's paricalcitol - available in three multi-dose vial configurations - is approved for the prevention and treatment of secondary hyperparathyroidism associated with Stage 5 chronic kidney disease (CKD). Hyperparathyroidism contributes to the development of metabolic bone disease.
Sterile use of multi-dose vials can reduce waste because the vial's entire contents can be utilized over time, as opposed to single-dose vials, which require clinicians to discard the unused volume of solution after drawing up the patient's specific dose. The current branded drug offers only one of three sizes as a multi-dose configuration.
"Hospira's paricalcitol injection will give US haemodialysis patients access to a high-quality, lower-cost alternative to the branded product, and increased dosing efficiency and reduced waste to healthcare providers in the renal dialysis and hospital dialysis markets. Paricalcitol reinforces Hospira's commitment to meet patient and caregiver needs in the renal space," said Philippe Drouet, president, US, Hospira.
Hospira will offer multi-dose configurations in 5 mcg and 10 mcg vials of paricalcitol in a 5 mcg/mL concentration, and then 2 mcg vials of paricalcitol in a 2 mcg/mL concentration. These are the concentrations that customers have used for many years.
Hospira's specialty injectable pharmaceuticals (SIP) offering includes approximately 200 generic injectable drugs in many dosages and formulations. In addition, many of its products are available in popular differentiated presentations, several of which are proprietary, such as ADD-Vantage™ drug delivery system and iSecure prefilled syringes. Therapeutic segments include analgesia, anaesthesia, anti-infectives, cardiovascular, oncology, emergency and other areas. Hospira also has robust pipelines of both generic and biosimilar drugs.
Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5.