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Published: 2022-11-14 09:01:38 CET
Company Announcement

FDA Formally Registers Transfer to J. Molner AS of 3 Drugs

The United States Food and Drug Administration ("FDA") formally listed the onwership and transfer to J. Molner's Estonian subisidiary, The J. Molner Company OÜ, of three approved Abbreviated New Drug Applications ("ANDAs") which the company previously acquired. As detailed in J. Molner's company description on 12 October 2022, it acquired the three drugs as part of a transaction earlier this year and has been executing the transfer of ownership and manufacturing. This official listing provides Molner the legal rights and abilities to operate with these marketing authorizations and execute the required changes to transfer the products to new manufacturing sites  


The three approved drugs include:

ANDA 209556 - Hydrocoritsone butyrate lotion 0.1% approved 21 November 2017 (J. Molner drug candidate MOL-001);

ANDA 201753 - Diflorasone diacetate ointment 0.05% approved 12 June 2018 (J. Molner drug candidate MOL-002); and,

ANDA 209973 - Desoximetasone ointment 0.05% approved 23 October 2018 (J. Molner drug candidate MOL-003).


FDA provides access to all approved drugs through its web portal available at: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm


         For further information:
         Jason Grenfell-Gardner
         The J. Molner Company
         +372 536 00 346