Thea Pharma Inc. Statement Related to Akorn's Voluntary Nationwide Recall of Various Human and Animal Drug Branded Ophthalmic Products within Expiry Due to Company Shutdown
Thea Portfolio of Products Acquired from Akorn are not Affected by this Recall
WALTHAM, Mass., April 28, 2023 /PRNewswire/ -- Thea Pharma Inc. ("Thea"), the U.S. subsidiary of Europe's leading independent pharmaceutical company, Laboratoires Théa, dedicated to the research, development, and commercialization of ophthalmic products, is responding to the recent statement related to the Akorn Operating Company LLC ("Akorn") voluntary nationwide recall. On April 26, 2023, the Akorn Trustee issued a company announcement that initiated a voluntary recall of various within-expiry human and animal products as a result of its U.S. facility closures and discontinuation of the Quality activities of these marketed products.
Akorn's recall announcement has raised questions related to the Thea portfolio of products, AcellFX™, Akten®, AzaSite®, Betimol®, Cosopt®, Cosopt® PF, and Zioptan® acquired last year from Akorn. These Thea products are not impacted by Akorn's recall. None of these products are manufactured at Akorn's U.S. facilities that have been closed.
For your reference, the Thea portfolio of products is described in the table below. Note that the Akorn and new Thea labeled versions of these products are equivalent and are both unaffected by the Akorn voluntary recall.
Thea Product Descriptions | Thea | Akorn NDC Codes |
Akten® (lidocaine hydrochloride ophthalmic gel) 3.5% | 82584-792-01 82584-792-25 | 17478-792-01 17478-792-25 |
AzaSite (azithromycin ophthalmic solution) 1% sterile | 82584-307-02 82584-307-03 | 17478-307-03 |
Betimol® (timolol ophthalmic solution) 0.25%, 0.5% | 82584-001-05 82584-002-05 82584-002-15 | 76478-001-05 76478-002-05 76478-002-15 |
Cosopt® (dorzolamide hydrochloride-timolol maleate | 82584-605-10 | 17478-605-10 |
Cosopt® PF (dorzolamide hydrochloride-timolol maleate | 82584-604-30 | 17478-604-30 |
Zioptan® (tafluprost ophthalmic solution) 0.0015% | 82584-609-30 | 17478-609-10 17478-609-30 |
About Théa
Laboratoires Théa is an independent pharmaceutical company specialized in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, it has thirty-five affiliates & offices in Europe, North and South America, North Africa, and the Middle East. Today, its network includes more than 1,600 employees, and its products are available in 75 countries around the world. In 2021, Théa had global revenues of approximately $773 million. The independent and family-owned and run group, founded from a Research and Development start-up by Henri Chibret, has been chaired since 2008 by Jean-Frédéric Chibret, his nephew.
To learn more about Laboratoires Théa Group, visit https://www.laboratoires-thea.com/en/Group
About Thea Pharma Inc.
Established in Lexington, Massachusetts in 2019, Thea Pharma Inc., is the United States fully owned subsidiary of Laboratoires Théa. Its product offering is comprised of a portfolio of leading eye-care products that are regulated or approved by the U.S. Food and Drug Administration (FDA), including AcellFX™, Akten®, AzaSite®, Betimol®, Cosopt®, Cosopt® PF, and Zioptan®, iVIZIA® dry-eye drops and eyelid hygiene products, and now IYUZEH™. By focusing our passion and expertise within the U.S. market, Thea's goal is to deliver uncompromising care that allows all stakeholders to envision the future of ophthalmic treatment with eyes wide open.
To learn more about Thea Pharma Inc., visit https://theapharmainc.com.
SOURCE Thea Pharma Inc.
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