J. Molner AS Gains US FDA Approval for First Estonian-Developed ANDA - Lidocaine Hydrochloride Topical Solution 4%Tallinn, 2024-04-30 08:30 CEST --
J. Molner AS, an Estonia-based generic pharmaceutical company listed on Nasdaq Tallinn First North, has been granted approval by the US Food and Drug Administration (FDA) for its first Estonian-developed Abbreviated New Drug Application (ANDA) for Lidocaine Hydrochloride Topical Solution 4%.The approval is a noteworthy milestone for the company, representing the culmination of an entirely in-house development process by the skilled J.Molner team of scientists and professionals.
Intended for the production of anesthesia of accessible mucous membranes of the oropharynx, this prescription-only medication is a generic version of the original reference listed drug Xylocaine. Based on the most recent IQVIA sales data as of March 2024, the market for such a product stands at an annual $11.3 million in the United States.
The progression from concept to regulatory approval exemplifies J. Molner AS's rigorous approach to product development, emphasizing the professional ethos of its team. The achievement is shared among all the members who contributed with their expertise and diligence.
“Receiving FDA approval for our Lidocaine Hydrochloride Topical Solution 4% is a significant moment for our company,” states Jason Grenfell-Gardner, Founder of J. Molner AS. “We take pride in our ability to contribute a fully in-house developed product to the healthcare market. Our team’s collective efforts have been crucial in bringing this essential medication to healthcare providers and patients.”
J. Molner AS anticipates the commercial launch of its Lidocaine Hydrochloride Topical Solution 4% in late Q3 2024, further solidifying its role as a dedicated player in the generic pharmaceutical market.
For more detailed information on J. Molner AS and its range of healthcare solutions, please visit www.jmolner.com.
For additional information please contact:
Jason Grenfell-Gardner
J. Molner AS
Management Board member
+372 536 00 346
jason@jmolner.com
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