MDIs and DPIs for Asthma and COPD, Sold in the US                                                                                                                                                                [February, 2003]

Drug Substance

CFC/ non-CFC/ DPI

Innovator/

Generic

Drug Product

Manufacturer

Approval Date

Source (Imported or Domestic)

Exported to Other Parties?

 

 

 

 

 

 

 

 

Short-Acting Bronchodilators:

Albuterol

CFC

Innovator

Proventil

Schering Plough

 

Domestic

No

Ventolin

GlaxoSmithKline

 

Domestic

Yes (Canada)

Generic

Albuterol

Andrx

 

Domestic

No

Albuterol

Sidmak

 

Domestic

No

Albuterol

Ivax

 

Imported (Ireland)

No

Non-CFC

Innovator

Proventil HFA

3M

8/15/1996

Domestic and Imported

No

Ventolin HFA

GlaxoSmithKline

4/19/2001 (launched 2/02)

Domestic

Yes (UK)

Epinephrine nitrate/HCl

CFC

Generic

Epinephrine Inhalation Aerosol

Alpharma

 

Domestic

No

Ipratropium Bromide

CFC

Innovator

Atrovent

Boehringer Ingelheim/ 3M

 

Domestic

No

Metaproterenol sulfate

CFC

Innovator

Alupent

Boehringer Ingelheim/ 3M

 

Domestic

No

Pirbuterol acetate

CFC

Innovator

Maxair Autohaler

3M

 

Domestic

No

 

 

 

 

 

 

 

 

Long-Acting Bronchodilators:

Formoterol fumarate

DPI

Innovator

Foradil Aerolizer

Novartis

2/16/2001

Imported

 No

Salmeterol xinafoate

CFC

Innovator

Serevent Inhalation Aerosol

GlaxoSmithKline

 

Domestic

Yes (Canada)

DPI

Innovator

Serevent Diskus

GlaxoSmithKline

9/19/1997

Imported (UK)

No

 

 

 

 

 

 

 

 

Corticosteroids:

Beclomethasone dipropionate

Non-CFC

Innovator

Qvar 40

3M

9/15/2000

Domestic and Imported

No

Qvar 80

3M

9/15/2000

Domestic and Imported

No

Budesonide

DPI

Innovator

Pulmicort DPI

AstraZeneca

6/24/1997

Imported

No

Flunisolide hemihydrate

CFC

Innovator

Aerobid

Hoffman LaRoche/ Forrest/ 3M

 

Domestic

No

Fluticasone propionate

CFC

Innovator

Flovent 44mcg

GlaxoSmithKline

 

Domestic

Yes (Canada)

 

 

Flovent 110mcg

GlaxoSmithKline

 

Domestic

Yes (Canada)

Flovent 220mcg

GlaxoSmithKline

 

Domestic

Yes (Canada)

DPI

Innovator

Flovent Rotadisk

GlaxoSmithKline

11/7/1997

Imported

No

 

 

 

 

 

 

 

 

Other Agents:

 

 

 

 

 

 

 

Cromolyn Sodium

CFC

Innovator

Intal

Aventis

 

Imported

No

Nedocromil Sodium

CFC

Innovator

Tilade

Aventis

 

Imported

No

 

 

 

 

 

 

 

 

Combination Products:

Salmeterol xinafoate/ fluticasone propionate

DPI

Innovator

Advair Diskus (100/50)

GlaxoSmithKline

8/24/2000

Imported

No

Advair Diskus (250/50)

GlaxoSmithKline

8/24/2000

Imported

No

Advair Diskus (500/50)

GlaxoSmithKline

8/24/2000

Imported

No

Albuterol sulfate/ Ipratropium bromide

CFC

Innovator

Combivent MDI

Boehringer Ingelheim

 

Domestic

Yes (Canada)