1 Neil Flanzraich Vice Chairman and President Pulmonary-Allergy Drugs Advisory Committee Meeting June 10, 2004.

Slides:



Advertisements
Similar presentations
Asthma Medication Administration Marcia Winston, MSN,CPNP,AE-C The Children’s Hospital of Philadelphia Division of Pulmonary Medicine.
Advertisements

"Determining the Regulatory Pathway to Market" Classification Heather S. Rosecrans Director, 510(k) Staff Office of Device Evaluation Center for Devices.
Delisting albuterol CFCs: Economic Considerations Randall Lutter, Ph.D. Chief Economist Office of Policy & Planning OPPl/OPl Randall Lutter, Ph.D. Chief.
CFCs in inhalers for asthma and COPD What’s happening? © 2009 United Nations Environment Programme Developed in association with the National Asthma Council.
Industry Trends and Tools for Generic Product Selection KATE KUHRT SHANGHAI JUNE 19-21, 2007.
History of the Montreal Protocol, FDA regulation of CFCs and Background to Meeting Robert J. Meyer, MD Director, ODE II / CDER.
Growth and Success through Partnering & Outsourcing.
Subsequent Entry Biologics (SEBs) – Canada Presentation to AIPLA Biotechnology Committee January 25, 2012 Daphne C. Lainson
Data protection and extension of patent rights TRIPS requirements & TRIPS-plus provisions Carlos Correa.
1 Bioequivalence of Highly Variable Drugs: Regulatory Perspectives Sam H. Haidar, R.Ph., Ph.D. Pharmacometrics Office of Generic Drugs.
Helping patients breathe more easily with affordable prescriptions Presented to Pulmonary-Allergy Advisory Committee U.S. Food and Drug Administration.
Experiences and lessons learned from essential use nominations in Article 2 Parties: European Community perspective Dr. Philippe Tulkens European Commission,
An Alternative to Pharmaceutical Patents Christian Engström Vice Chairman, The Swedish Pirate Party.
History of the Montreal Protocol and 21 CFR Robert J. Meyer, MD Director, ODE II / CDER.
Patients Will Be Adequately Served Richard P. Rozek* *The underlying economic research was conducted with Emily Bishko. GlaxoSmithKline provided financial.
CFC Essential Use Status of Albuterol: Medical Considerations Pulmonary-Allergy Drugs Advisory Committee Meeting June 10, 2004 Eugene J. Sullivan, MD,
ITFG/IPAC Collaboration Introduction OVERVIEW OF ITFG/IPAC COLLABORATION Presented by: Harris Cummings, PhD 26 April 2000 Rockville, MD.
Albuterol 180 Mcg Proventil Price unit cost albuterol 90ipratrop albuterol sulfate routes of administration nebulizer with albuterol side effects albuterol.
Nebulizer Albuterol Cartridge Buy Proventil Online albuterol dose for 6 month old long acting albuterol inhaler albuterol smell albuterol japan albuterol.
Albuterol Nebulizer Works Cheap Albuterol For Sale proventil and its antidote side effects of liquid albuterol albuterol sulfate muscle growth order albuterol.
Whats Albuterol Inhaler In Hebrew Cheap Albuterol Meds primatene mist vs. proventil albuterol inhaler price no insurance albuterol nebulizer treatment.
MDI market analysis and cost comparison in Hungary Róbert Tóth Ministry of Environment and Water Budapest, Hungary.
Albuterol 2.5 Mg Albuterol Price how much does albuterol 90 ipratrop 18 mcg cost can albuterol given iv albuterol sulfate inhalation.083 to buy albuterol.
Can A Preemie Use Albuterol In Nebulizer Cheap Proventil For Sale albuterol category where can you buy albuterol in europe albuterol dosage adults nebulizers.
Buy Proventil Inhaler Online Buy Cheap Proventil albuterol dosage continuous nebulizer proventil inhaler dosage albuterol while pregnant albuterol sulfate.
Buy Albuterol Using Paypal Cheap Proventil For Sale albuterol empty albuterol facmed xopenex better than albuterol albuterol pills for horses can albuterol.
Liquid Albuterol For 16 Month Old Proventil Cheap can albuterol nebulizer be given with benadryl albuterol ipratropium drug price of proventil penicillin.
Buying Albuterol Online From Mexico Cheap Generic Proventil albuterol and infants side effects proventil hfa inhaler cost nebulizer albuterol side effects.
Buy Albuterol Sulfate Cheap Proventil No Prescription pro air albuterol where to buy in bangalore can you overdose on albuterol albuterol syrup 1 yr old.
Albuterol And Benadryl Drug Interactions Cheap Proventil Online albuterol with spacer price effects of beer with liquid albuterol albuterol act albuterol.
Albuterol Coupon 2015 Albuterol Online Coupon albuterol nebulizer solution without prescription albuterol inhaler beta blocker does albuterol and pulmicort.
Albuterol Vs Qvar Cheap Proventil Meds kind inhaler proventil albuterol cost no insurance holistic substitute for albuterol sulfate albuterol syrup.
Albuterol Without Prescription Cheap Cheap Proventil Online can i give albuterol sulfate to my 2 month old baby use proventil inhaler albuterol syrup side.
Albuterol And Ibuprofen Cheap Albuterol For Sale albuterol inhaler dosage for cats how to cycle albuterol t3 keto running on albuterol albuterol overdose.
What Is The Over The Counter Albuterol Pills Cheap Generic Proventil albuterol nasal dose inhaler albuterol on infants albuterol 2mg 5ml syrup high dose.
How Big Is A 17g Albuterol Inhaler Cheap Proventil Online amoxicillin refill albuterol nebulization machine albuterol have steroids proventil drug classification.
Albuterol Medicine For Sale Cheap Proventil Without Prescription where to purchase albuterol aerosol side effects of albuterol nebulizer for infants albuterol.
Albuterol Route Of Administration Albuterol Online Coupon how to treat a horse with albuterol albuterol nebulizer rsv albuterol sulfate for 7 month old.
Albuterol Bullets Cheap Generic Proventil about albuterol sulfate proventil albuterol sulfate dangers albuterol sulfate is a steroid albuterol vs.
Proventil Online Pharmacy Cheap Albuterol Online albuterol sulf er awp albuterol inhaler albuterol ld50 proventil hfa 90 mcg using beyond expiration date.
Albuterol Reviews Purchase Proventil Online albuterol nclex questions albuterol ipratropium brand name what is albuterol sulfate.083 purchase albuterol.
Proventil Hfa How To Use Cheap Proventil For Sale albuterol inhaler and ibuprofen over night albuterol albuterol sulfate nebulizer en espanol albuterol.
Can I Get Albuterol Sulfate Without A Prescription Cheap Generic Proventil albuterol sulfate inhaler medicine is ok to give a 2 year old albuterol
Global Smart Inhalers Sales Market Report 2017
Is It Safe To Use Albuterol While Pregnant
Order Albuterol Inhalers
Purchase Ventolin Inhaler
Generic Medicines.
CFCs in inhalers for asthma and COPD
Presentation transcript:

1 Neil Flanzraich Vice Chairman and President Pulmonary-Allergy Drugs Advisory Committee Meeting June 10, 2004

2 IVAX Corporation Multinational Corporation Multinational Corporation Leading Generic Company Leading Generic Company Albuterol Inhalation Aerosol (CFC) Albuterol Inhalation Aerosol (CFC) Verapamil HCl ER Tablets Verapamil HCl ER Tablets Paclitaxel Injection Paclitaxel Injection Extensive Proprietary Drug Pipeline Extensive Proprietary Drug Pipeline Strong Focus on Products for Respiratory Conditions Strong Focus on Products for Respiratory Conditions

3 Leader in Providing Generic Albuterol Inhalation Aerosol (CFC) First U.S. Generic Albuterol Inhaler First U.S. Generic Albuterol Inhaler FDA Interactions – Establishing Guidance FDA Interactions – Establishing Guidance Expanded Use of Albuterol Expanded Use of Albuterol Significant Reduction in Price Significant Reduction in Price

4 Leader in Providing CFC-Free Branded Respiratory Products IVAX’ 17-year Commitment to Development IVAX’ 17-year Commitment to Development World’s First CFC-Free Beclomethasone in MDI World’s First CFC-Free Beclomethasone in MDI QVAR – First CFC-Free Aerosol Corticosteroid for Asthma in U.S. QVAR – First CFC-Free Aerosol Corticosteroid for Asthma in U.S. NDA Filed Jan for HFA Albuterol in MDI (Received Approvable Letter 11/28/03) NDA Filed Jan for HFA Albuterol in MDI (Received Approvable Letter 11/28/03) NDA Filed Aug for HFA Albuterol in IVAX’ Patented Breath Activated Easi-Breathe ® Inhaler NDA Filed Aug for HFA Albuterol in IVAX’ Patented Breath Activated Easi-Breathe ® Inhaler IVAX’ Other CFC Alternatives IVAX’ Other CFC Alternatives Dry Powder Inhaler Airmax™ Dry Powder Inhaler Airmax™ Inhalation Solution Products for Nebulization Inhalation Solution Products for Nebulization

5 Health Concerns Depletion of Stratospheric Ozone Health Risks Depletion of Stratospheric Ozone Health Risks Increase Formation of Ground Level Ozone Health Risks Increase Formation of Ground Level Ozone Health Risks

6 IVAX’ HFA Albuterol MDI and HFA Albuterol Easi-Breathe Will Meet FDA Regulations on Same Active Moiety, Same Route of Administration, Same Indications and Approximately Same Level of Convenience of Use Will Meet FDA Regulations on Same Active Moiety, Same Route of Administration, Same Indications and Approximately Same Level of Convenience of Use Will Provide at Least One Year of Post Marketing Data on Equivalent HFA Albuterol Products Sold in Europe Will Provide at Least One Year of Post Marketing Data on Equivalent HFA Albuterol Products Sold in Europe

7 IVAX’ HFA Albuterol MDI and HFA Albuterol Easi-Breathe Capacity Capacity FDA Approved Plant in Waterford, Ireland FDA Approved Plant in Waterford, Ireland Million Units a Year in the Near Term Million Units a Year in the Near Term CFC Availability is Rapidly Decreasing in Europe CFC Availability is Rapidly Decreasing in Europe

8 IVAX and Pricing 17 Years of Demonstrated Commitment to Affordable Medicine – Generic and Branded Products 17 Years of Demonstrated Commitment to Affordable Medicine – Generic and Branded Products Substantial Free Sampling Program Substantial Free Sampling Program Patient Assistance Program Patient Assistance Program Additional Competitors Create Downward Pricing Pressure Additional Competitors Create Downward Pricing Pressure

9 IVAX Request Based on: Continued CFC Hazards Continued CFC Hazards FDA Criteria for Removal Now Met FDA Criteria for Removal Now Met Huge Industry Investments Huge Industry Investments US Pledge to Citizens and International Community US Pledge to Citizens and International Community IVAX Request: Removal of Essential Use Exemption, Effective no Later than Dec. 31, 2005 Removal of Essential Use Exemption, Effective no Later than Dec. 31, 2005

10