ProHealth fibromyalgia Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Lady Gaga Documentary Reveals the Severity of Her Fibromyalgia Pain

VIDEO: Fibromyalgia is Real - A Video for Nonbelievers

Unravelling the Mysteries of ME/CFS and Fibromyalgia: Meet the Man Behind the Book

Is the Fibro-fog in Fibromyalgia a Prelude to Dementia?

An Overlooked Issue in Fibromyalgia? Study Highlights Problems Standing (Orthostatic Intolerance)

Why Lady Gaga having fibromyalgia is both a blessing and curse for the fibromyalgia community

How Myofascial Release Got Me Back On My Feet Again

Born this Way – Me & Lady Gaga

Pain and Prejudice: Surviving Fibromyalgianess

Lymphatic Massage, Clogged Drains and Fibromyalgia Pain

 
Print Page
Email Article

Ampligen New Drug Application Process Clears Another Hurdle

  [ 10 votes ]   [ Discuss This Article ]
www.ProHealth.com • August 14, 2012


News today across the wired ME/CFS community is that...
The US Food and Drug Administration has accepted and pronounced complete Hemispherx Biopharma Inc.s ‘response submission’ regarding its New Drug Application for Ampligen® as a therapy for Chronic Fatigue Syndrome (ME/CFS).

On Aug 10, the FDA stated in writing that "We consider this a complete, class 2 response to our November 25, 2009, action letter.”

The decision begins a six-month FDA review cycle...
Including analysis of new supplemental clinical data that Hemispherx submitted to the FDA from its past Ampligen trials “in lieu of the additional confirmatory Phase III study originally called for in the Agency’s CRL.” (The FDA’s first Complete Response Letter to Hemispherx on Nov 29, 2009, regarding Hemispherx’s first submission of research data.)

For an explanation of the supplemental data involved, go to http://www.hemispherx.net/content/investor/default.asp?goto=736.

Hemispherx Executive Vice Chair Thomas Equels states...
"Since no drug has yet received FDA approval to treat CFS, we are committed to working with the FDA as well as making an all-out effort by our staffs in New Jersey and Philadelphia, along with the necessary and appropriate investment in additional personnel, equipment and other resources, in the hope of getting a treatment approved for people who must live with this severely debilitating condition."




Post a Comment

Featured Products From the ProHealth Store
FibroSleep™ Guaifenesin FA™ Optimized Curcumin Longvida®


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Fibro Freedom™ Fibro Freedom™
Soothes, Strengthens & Revitalizes
Guaifenesin FA™ Guaifenesin FA™
Helps the Body Eliminate Excess Calcium and Phosphates
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health

Natural Remedies

Mitochondria-Booster NIAGEN® Shows Promise in First Human Clinical Trial Mitochondria-Booster NIAGEN® Shows Promise in First Human Clinical Trial
Natural Bladder Control, Go Less and Live More Natural Bladder Control, Go Less and Live More
Research Links Green Tea to Weight Loss Research Links Green Tea to Weight Loss
Thyroid Health and Fibromyalgia Thyroid Health and Fibromyalgia
Running on Empty? Fuel Up with NADH Running on Empty? Fuel Up with NADH

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map