The FDA has granted temporary discretion to import erythromycin ophthalmic ointment for the treatment of newborns.
LSL Pharma Group Inc today announced it has entered into an exclusive agreement with Fera Pharmaceuticals, LLC to provide erythromycin ophthalmic ointment USP (5mg/g) for the treatment of newborn infants in US hospitals.
Amid a scarcity of erythromycin ophthalmic ointment, the FDA granted Fera temporary discretion to import from Canada the medication used in the prevention of gonococcal ophthalmia neonatorum.1
According to a news release, Under the terms of the deal, LSL Pharma Group, through its manufacturing subsidiary Steri-Med Pharma Inc., could initially supply up to 25% of the 4 million doses required annually in the US hospital market. More erythromycin ophthalmic ointment may become available if the drug shortage persists, according to the release.
François Roberge, president and CEO of LSL Pharma Group, noted in the news elease the company is pleased to respond to this urgent healthcare need by making our eye medication readily available to the US market.1
“The priority, after all, is safeguarding the health and well-being of vulnerable newborns. This opportunity is a testament to the solid reputation that Steri-Med is gaining in the global market for sterile ophthalmic medications,” Roberge said in a statement in the news release. “We hope that this collaboration will go a long way in meeting patient needs today and opening new doors for the future.”
“We appreciate the collaboration with FDA and Steri-Med in order to ensure adequate supply in the U.S. of this important product,” Frank DellaFera, president and CEO of Fera, said in the news release.
1. LSL Pharma Group Announces Exclusive Distribution Agreement With Fera Pharmaceuticals to Alleviate Drug Shortage in U.S. Hospitals. Global Newswire. Published October 18, 2023. Accessed October 18, 2023. https://financialpost.com/globe-newswire/lsl-pharma-group-announces-exclusive-distribution-agreement-with-fera-pharmaceuticals-to-alleviate-drug-shortage-in-u-s-hospitals