The injection therapy was a previously non-approved FDA product that was grandfathered into marketed use for about 4 decades.
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) for calcium chloride injection 10% in the Luer-Jet Prefilled Syringe System, from Amphastar Pharmaceuticals.
The injection therapy was a previously non-approved FDA product that was grandfathered into marketed use for about 4 decades under the administration’s Prescription Drug Wrap-Up program, according to Amphastar. The injection had generated a net revenue of $13.5 million in the previous calendar year.
Calcium chloride injection 10% is generally used for immediate treatment of hypocalcemic tetany, electrolyte imbalance, or in care of cardiac resuscitation. It can also be used treat certain cases of insect bites or stings.
Jack Zhang, PhD, Amphastar chief executive officer, said the approval is indicative of the company’s collaborative effort to alleviate drug shortages. A majority of the company’s marketed products are used in hospital or urgent care clinical settings.
Amphastar, a specialty pharmaceutical company with a focus on developing generic and proprietary injectable and inhalation products, currently has another 4 marketed products unapproved by the FDA. There are 2 ANDAs and one new drug application (NDA) pending decision for such therapies.