AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.
Create a link to this page
Copy and paste this link tag into your Web page or blog:
IVAX Receives FDA Approvable Letter for Albuterol HFA in Breath-Activated Inhaler.
MIAMI -- IVAX Corporation (AMEX:IVX)(LSE:IVX.L) announced today that it has received an approvable letter from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for albuterol sulfate using non-ozone-depleting, CFC-free propellant in IVAX' patented breath-activated aerosol inhaler.
Albuterol, a beta-agonist bronchodilator, is the primary rescue medicine for the relief of asthma symptoms. Over 90% of the more than 50 million albuterol inhalers sold in the U.S. last year contained chlorofluorocarbon (CFC) propellants, which are expected to be eventually removed from the market due to concern about ozone depletion. On June 16, 2004, the FDA issued a proposed rule to remove the essential-use designation for CFC albuterol inhalers. IVAX' formulation of albuterol uses hydrofluoroalkane (HFA), a non-ozone-depleting, CFC-free propellant.
IVAX' patented breath-activated aerosol inhaler, marketed in Europe under the name Easi-Breathe(R), is the best-selling breath-activated aerosol inhaler in the United Kingdom, the world's second largest asthma market. This inhaler eliminates the need to coordinate the manual release of the medicine with inhalation of the medicine, which is required by standard metered dose inhalers. Such coordination can be difficult and sub-optimal synchronization can result in the medicine not reaching the lungs.
Upon receipt of final FDA approval, IVAX will market this product through its wholly owned subsidiary, IVAX Laboratories, Inc. IVAX has previously received an approvable letter from the FDA on a separate NDA for an HFA formulation of albuterol in a standard metered dose inhaler.
IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally.
Copies of this and other news releases may be obtained free of charge from IVAX' website at ...
- Ivax receives FDA approvable letter for albuterol HFA in breath-activated...
- News wire article from: Asia Africa Intelligence Wire July 7, 2004 700+ words
...Business NewsBase - Press Release) Ivax Corp has received an approvable letter from the US Food & Drug...depleting, CFC-free propellant in Ivax's patented breath-activated...concern about ozone depletion. Ivax's patented inhaler, marketed...
- Chemical Market Reporter: Ivax receives approvable letter for metformin.
- News wire article from: Chemical Business Newsbase December 3, 2001 700+ words
Ivax has received an FDA approvable letter for metformin hydrochloride, a generic version of Bristol-Myers Squibb's Glucophage tablets. Final approval is dependent on resolving paediatric labelling.
- FDA issues approvable letter for Albuterol HFA in breath-activated inhaler.
- Newspaper article from: Medical Devices & Surgical Technology Week August 1, 2004 700+ words
...amp; NewsRx.net) -- IVAX Corporation (IVX) has received an approvable letter from the U.S. Food and...wholly owned subsidiary, IVAX Laboratories, Inc. IVAX has previously received an approvable letter from the FDA on a separate...
- Teva Receives Follow-up Approvable Letter from FDA Regarding Agilect(R).
- Press release article from: Business Wire August 5, 2005 700+ words
...whether and when the proposed acquisition with Ivax Corporation will be consummated and the terms...of the financing utilized by Teva for the Ivax acquisition, Teva's ability to rapidly integrate Ivax's operations and achieve expected synergies...
- Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional...
- Press release article from: PR Newswire December 13, 2007 700+ words
...10 mg capsules were approvable (2006 Approvable Letter). The 2006 Approvable Letter requested that the company reanalyze...middle of the night dosing. The 2006 Approvable Letter also requested reexamination of the safety...
- Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol.
- Press release article from: PR Newswire May 31, 2007 700+ words
...announced that it has received a second approvable letter from the U.S. Food and Drug Administration...formulation of tramadol. In the second approvable letter (dated May 30, 2007), the FDA...assessment of our response to its initial approvable letter," said James R. Howard-Tripp...
- FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic(R) -...
- News wire article from: The America's Intelligence Wire July 10, 2006 700+ words
...gentlemen, and welcome to the FDA Issues Approvable Letter to Cellegy Pharmaceuticals (indiscernible...technical difficulty) -- received an approvable letter from the FDA on our NDA for Cellegesic...December 2004 where we received a not approvable letter from the FDA, and we now have ...
- JAZZ PHARMACEUTICALS INC Conference Call to Discuss FDA Approvable Letter for...
- News wire article from: Fair Disclosure Wire December 24, 2007 700+ words
...on Friday, the FDA has issued an approvable letter for LUVOX CR. In the letter, FDA...by reminding you that the previous approvable letter for LUVOX CR, which was issued by...issue was not raised in Friday's approvable letter, and we believe it has been resolved...
- FDA Issues Approvable Letter for Expanded Use of Vivelle-Dot and Addition of...
- Press release article from: Business Wire December 11, 2001 700+ words
...Novartis Pharmaceuticals Corporation an approvable letter relating to the expanded use of Vivelle...The expanded use addressed in the approvable letter includes the prevention of postmenopausal...075 and 0.1 mg/day). The approvable letter relates to the addition of a new...
- EPIX Pharmaceuticals Receives Second Approvable Letter for Vasovist(TM) from...
- Press release article from: Business Wire November 23, 2005 700+ words
...has provided the Company with an "approvable" letter related to the Company's novel...Vasovist(TM). This is the second approvable letter received by the Company from the...submitted a response to the FDA's approvable letter received in January 2005, which...
Source: HighBeam Research, IVAX Receives FDA Approvable Letter for Albuterol HFA in...