FDA Acknowledges MannKind Resubmission of NDA for AFREZZA

Loading...
Loading...
MannKind Corporation
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
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
See full press release
Market News and Data brought to you by Benzinga APIs
Posted In: NewsGuidanceContractsFDAManagementGlobal
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...