Dey Pharma Product History

A History of Firsts

1978 Sterile Unit-Dose Sodium Chloride Solutions for Inhalation

Dey Founded

First Introduces Sterile Unit-Dose Sodium Chloride Solutions for Inhalation

1986 Sterile Acetylcysteine Solutions

First Generic Sterile Acetylcysteine Solutions

1987 Sterile Unit-Dose Generic Metaproterenol Sulfate Inhalation Solution

First FDA-Approved Sterile Unit-Dose Generic Metaproterenol Sulfate Inhalation Solutions

1992 Sterile Unit-Dose Generic Albuterol Sulfate Inhalation Solution

First FDA-Approved Sterile Unit-Dose Generic Albuterol Sulfate Inhalation Solution

1994 Sterile Unit-Dose Generic Cromolyn Sodium Inhalation Solution in Plastic Vial

First FDA-Approved Sterile Unit-Dose Generic Cromolyn Sodium Inhalation Solution in a Plastic Vial

1997 Unit-Dose Sterile Generic Ipratropium Bromide Inhalation Solution

First FDA-Approved Unit-Dose Sterile Generic Ipratropium Bromide Inhalation Solution

1999 Curosurf® (poractant alfa)

Curosurf® (poractant alfa) Intratracheal Suspension porcine lung surfactant (in cooperation with Chiesi Farmaceutici, S.p.A., Parma, Italy)

2001 EpiPen® 2-Pak™ and EpiPen® Jr. 2-Pack™

EpiPen® 2-Pak™ and EpiPen® Jr. 2-Pak™ plus trainer device

2001 AccuNeb™ (albuterol sulfate) Inhalation Solution

AccuNeb™ (albuterol sulfate) Inhalation Solution — First premixed, premeasured, and preservative-free lower-concentration albuterol, FDA-Approved for kids 2 to 12

2001 DuoNeb™ (ipratropium bromide and albuterol sulfate)

DuoNeb™ (ipratropium bromide and albuterol sulfate) patented Inhalation Solution - First and only one-step, dual therapy nebulizer solution, FDA-approved

2007 Perforomist® (formoterol fumarate)

Perforomist® Inhalation Solution

WARNING: ASTHMA-RELATED DEATH
Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST Inhalation Solution. The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS).

Important Safety Information
PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.

PERFOROMIST Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

Please see full Prescribing Information, including Boxed Warning

2009 EpiPen® with improved needle/sharps protection

EpiPen® Auto-Injector with enhanced patient-friendly features including needle-protection

After injecting EpiPen, patients should call 911 or seek emergency medical treatment.

Please see full Prescribing Information

2009 EMSAM® selegiline transdermal system

EMSAM® (selegiline transdermal system)

Antidepressants increase the risk compared to placebo of suicidality in children, adolescents and young adults. EMSAM is not approved for pediatric patients.

Please see full Prescribing Information, including Boxed Warning