MannKind Announces FDA Acknowledgement of Resubmission of New Drug Application for AFREZZA
2017-10-30 · Mannkind Corporation · original mannkindcorp.com ↗
VALENCIA, Calif.--(BUSINESS WIRE)--Oct. 30, 2013-- MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for AFREZZA® (insulin human [rDNA origin]) Inhalation Powder. The FDA considered the updated NDA to be a complete class 2 response to its Complete Response Letter issued in January 2011 and assigned a user fee goal date of April 15, 2014. About MannKind Corporation MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. Its lead product candidate, AFREZZA®, has completed Phase 3 clinical trials. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website. Source: MannKind Corporation Company Contact: MannKind Corporation Matthew Pfeffer Chief Financial Officer 661 775-5300 [email protected] or Media Inquiries: MCS Healthcare Public Relations Laura De Zutter or Jeff Hoyak 800 477-9626 [email protected] [email protected]
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