Afaxys Addresses Decade Long Shortage of an FDA Listed Essential Medicine
Afaxys’ Lidocaine Hydrochloride Injection USP, 1% (200 mg/20mL (10mg/mL)) Multi-Dose Vial Received Approval from the U.S. Food and Drug Administration
CHARLESTON, S.C. – Afaxys Pharma, LLC, operating under the Afaxys family of companies, announced today it received approval from the U.S. Food and Drug Administration (FDA) on Lidocaine Hydrochloride Injection USP, 1% (200 mg/20mL (10mg/mL)) Multi-Dose Vials to help address the decade long, ongoing shortage of lidocaine. It will be commercially available to order soon through Afaxys Pharma and the Afaxys GPO in the United States.
Every year, more than 31 million Americans rely on community and public health centers to get essential care, including sexual and reproductive services. Yet, in today’s changing and uncertain healthcare environment many of these providers struggle to serve their patients because they cannot access the cost-effective products they need due to various reasons including: manufacturing delays, increased demand, recalls and pandemic related issues.
“The product shortage has made it difficult for healthcare providers to deliver key services to patients,” said Preeti Churbock, Senior Marketing Director, Afaxys. “We listened to our customers who identified a gap in patient care and acted on our mission to ensure healthcare providers have reliable access to affordable, quality, FDA-approved products needed for those seeking sexual and reproductive care.”
Afaxys Pharma submitted an Abbreviated New Drug Application (ANDA) to the FDA in July 2021. Lidocaine is listed as an essential medicine by the FDA and has been since the agency first published the list in October 2020 following a Presidential Executive Order. This executive order directed the FDA to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.
“When lidocaine is not available, procedures must be delayed or cancelled since pain control is important to both healthcare providers and patients,” said Dr. Kristen Feldman, Medical Director at Afaxys and Gynecologist with Carolina Gynecology. “In the healthcare space, it is used during a wide variety of medical procedures such as skin biopsies, procedures to treat cervical “precancer,” and birth control implant insertions.”
Lidocaine is a local anesthetic that is used to numb an area of the body in certain medical and dental procedures to help reduce pain. It is available in multiple doses and delivery systems including topical solutions, skin patches and injections. Adverse reactions following the administration of lidocaine hydrochloride are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. These can lead to central nervous system, cardiovascular, allergic, neurologic, or hematologic (i.e., methemoglobinemia) effects.
About Afaxys
Afaxys, whose name is derived from a combination of affordable and access, is a first-of-its-kind socially conscious healthcare company inspired by the need to solve a public health crisis. The organization uniquely partners with community and public health, and private industry to ensure healthcare providers have stable pricing and reliable access to the products and services they need to care for their patients.
The Afaxys enterprise comprises a family of companies that operate under two wholly owned subsidiaries: Afaxys Pharma, LLC and Afaxys Group Services, LLC (AGS). Afaxys Pharma provides a broad portfolio of branded and generic contraceptives to the public healthcare market. AGS is a strategic sourcing operation that negotiates favorable pricing across a broad base of products and services through its Group Purchasing Organization and emapp. For more information visit www.afaxys.com.
PR06142022
Company Contact
Afaxys
Staci Gouveia, Director, Corporate Communications & PR
staci.gouveia@afaxys.com
843-513-1793
www.afaxys.com