US FDA Type III Drug Master File submitted for capsule inhaler ICOcap® from Iconovo

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Iconovo announce that the capsule-based dry powder inhaler ICOcap® has been submitted to U.S. Food and Drug Administration (FDA) by partner Stevanato as Type III Drug Master File. New customers to ICOcap® can now reference this DMF submission when developing their drug-device product for the US market. This FDA submission follows a receival of CE-mark in European Union for clinical trials with ICOcap®.

”Stevanato is doing a great job in getting the ICOcap® inhaler globally ready for pharmaceutical companies to develop their products with ICOcap®. Now they have managed to take major steps in two of the largest markets in the world. US, the largest pharma market in the world, is a crucial market to be in with ICOcap®”, says Johan Wäborg, CEO for Iconovo.

About ICOcap

ICOcap is a patented capsule-based dry powder inhaler with a one-piece-design and improved handling features making it easy-to-use. It is currently designed with a low flow resistance but can be customized to a flow resistance of choice. ICOcap™ is available from Stevanato for quick product launch and competitively priced off-the-shelf supply.

Contacts

Johan Wäborg, CEO
+46 707 78 51 71
johan.waborg@iconovo.se

About Iconovo

Iconovo was founded in 2013 by people with long experience in inhalation development. The company develops inhalers and associated drug preparations that are used to treat asthma and COPD. However, Iconovo also has the competence to develop products for new types of inhaled drugs such as vaccines.

By working with Iconovo, pharmaceutical companies and generic companies can access a complete pharmaceutical product, thereby eliminating the complex and costly early stages of the development phase. Iconovo licenses its patented products to customers and offers a faster way to the inhalation market with lower risk and at a lower cost.

More information about the company can be found at www.iconovo.se.

Iconovo is based in Lund and its share (ticker ICO) is listed on Nasdaq First North Growth Market, Stockholm since April 6, 2018. The Company’s Certified Adviser is Erik Penser Bank AB, Box 7405, SE-103 91 Stockholm, phone +46 8 463 80 00, email: certifiedadviser@penser.se.

Attachments

US FDA Type III Drug Master File submitted for capsule inhaler ICOcap® from Iconovo