MannKind Updates Status of New Drug Application for AFREZZA(R)
April 07 2014 - 4:00AM
MannKind Corporation (Nasdaq:MNKD) today announced that the U.S.
Food and Drug Administration (FDA) has extended the Prescription
Drug User Fee Act (PDUFA) date for AFREZZA® by three months to July
15, 2014 in order to provide time for a full review of information
submitted by MannKind in response to the FDA's requests.
About AFREZZA®
AFREZZA® (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime
insulin therapy developed by MannKind Corporation to improve
glycemic control in adult patients with type 1 or type 2 diabetes.
It is a drug-device combination product, consisting of AFREZZA
Inhalation Powder delivered using a small, discreet and easy-to-use
inhaler. Administered at the start of a meal, AFREZZA Inhalation
Powder dissolves immediately upon inhalation to the deep lung and
delivers insulin quickly to the bloodstream. Peak insulin levels
are achieved within 12 to 15 minutes of administration, compared to
45-90 minutes for injected rapid acting insulin analogs and 90-150
minutes for injected regular human insulin.
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®, is under review by the FDA. MannKind regularly
posts copies of its press releases as well as additional
information about MannKind on its website www.mannkindcorp.com.
Interested persons can subscribe on the 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.
CONTACT: Investors:
Matthew J. Pfeffer
Chief Financial Officer
MannKind Corporation
mpfeffer@mannkindcorp.com
(661) 775-5300
Media:
Laura de Zutter
MCS Healthcare Public Relations
laurad@mcspr.com
(908) 234-9900
Jeff Hoyak
MCS Healthcare Public Relations
jeffh@mcspr.com
(908) 884-6753
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