New Drug Approvals Archive

Seroquel (quetiapine)

New Indication Approved: January 12, 2004

• AstraZeneca Receives FDA Approval for Seroquel for Treatment of Mania Associated with Bipolar Disorder

Acetadote (acetylcysteine) Injection

Date of Approval: January 23, 2004
Company: Cumberland Pharmaceuticals
Treatment for: Acetaminophen Overdose

Acetadote (acetylcysteine) is an injectable treatment to prevent or lessen potential liver damage resulting from acetaminophen overdose.

• Acetadote Cumberland Pharmaceuticals - Treatment for Acetaminophen Overdose

Acetadote (acetylcysteine) FDA Approval History

Caduet (amlodipine and atorvastatin) Tablets

Date of Approval: January 30, 2004
Company: Pfizer Inc.
Treatment for: Hypertension, Angina Pectoris

Caduet (amlodipine and atorvastatin) is calcium channel blocker and HMG-CoA reductase inhibitor combination used for the treatment of hypertension, angina and for the prevention of cardiovascular disease.

• Caduet High Blood Pressure and High Cholesterol - Treatment for High Blood Pressure and High Cholesterol

Caduet (amlodipine and atorvastatin) FDA Approval History

Spiriva (tiotropium bromide) Inhalation Powder - formerly Spiriva HandiHaler

Date of Approval: January 30, 2004
Company: Boehringer Ingelheim
Treatment for: Chronic Obstructive Pulmonary Disease -- Maintenance

Spiriva HandiHaler (tiotropium bromide) is an anticholinergic indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations.

• Spiriva HandiHaler Boehringer Ingelheim - Treatment for Chronic Obstructive Pulmonary Disease (COPD)

Spiriva (tiotropium bromide) FDA Approval History

Acetadote (acetylcysteine)

Labeling Revision Approved: December 12, 2008

• Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote

Acetadote (acetylcysteine) FDA Approval History

Spiriva (tiotropium bromide)

Labeling Revision Approved: December 17, 2009

• FDA Approves Spiriva HandiHaler for the Reduction of COPD Exacerbations

Spiriva (tiotropium bromide) FDA Approval History