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New Drug Approvals Archive - January 2004

January 2004

January 13

Seroquel (quetiapine)

New Indication Approved: January 12, 2004

January 23

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 (acetylcysteine) FDA Approval History

January 30

Caduet (amlodipine and atorvastatin) Tablets

Date of Approval: January 30, 2004
Company: Pfizer Inc.
Treatment for: Hypertension, Dyslipidemia, 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 (amlodipine and atorvastatin) FDA Approval History

January 30

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 (tiotropium bromide) FDA Approval History

December 19

Acetadote (acetylcysteine)

Labeling Revision Approved: December 12, 2008

Acetadote (acetylcysteine) FDA Approval History

December 18

Spiriva (tiotropium bromide)

Labeling Revision Approved: December 17, 2009

Spiriva (tiotropium bromide) FDA Approval History

New Drug Approvals Archive