Premier’s ProvideGx program to make the first FDA-approved version of cysteine hydrochloride available to providers
Premier Inc. has announced that through its ProvideGx program, it is now supplying cysteine hydrochloride injection to providers, a critical drug for pediatric and adult patients that require total parenteral nutrition (TPN). Cysteine hydrochloride has been in shortage in the U.S. since 2015.
This FDA-approved New Drug Application (NDA) for cysteine hydrochloride injection is held by Exela Pharma Sciences, LLC, a U.S.-based manufacturer. Current supplies of cysteine hydrochloride injection are imported from Canada under special FDA rules that allow shortage drugs to be sourced abroad if no domestic supplies are available.
Cysteine hydrochloride is indicated to meet the nutritional needs of newborn infants requiring total parenteral nutrition (TPN), as well as adult and pediatric patients with severe liver disease who may require TPN. It can also be added to amino acid solutions for protein synthesis. Exela’s FDA-approved NDA for cysteine hydrochloride is labeled to contain no more than 120 parts per billion (ppb) or mcg/L of aluminum. The FDA has been advocating for reduced aluminum levels in many injectable products, including cysteine hydrochloride, particularly for neonatal patients. According to extensive literature and evidence, high aluminum levels put these patients at risk for aluminum toxicity, which has been associated with impaired neurologic development.
After a period of decline, drug shortages in America increased significantly in 2018, with an estimated 124 drugs currently at risk or not readily available for U.S. hospitals, according to the FDA’s drug shortage list. With wide-ranging effects on patient care, drug shortages can add time and expense as providers search for therapeutic alternatives and manage supplies, potentially delaying certain elective hospital procedures.
“This partnership is expected to allow Premier members to have uninterrupted access to the only domestic, FDA-approved version of cysteine hydrochloride injection – a first in the industry,” said Premier’s President, Michael J. Alkire, in a press release.
The ProvideGx program is charged with identifying safe, high-quality supply sources for drugs that are or may be at risk of being added to the national drug shortage list. ProvideGx is the next step in Premier’s ongoing effort to help facilitate the availability of hundreds of high-quality products, including drugs for which there may be supply challenges. Premier says it is working with a robust pipeline of high-quality manufacturers to identify sources of product supply and to explore and implement solutions to address specific market needs.
