New Drug Approvals Archive

New Drug Approvals: June 2004

June 4
Istalol (timolol maleate ophthalmic) Solution

Date of Approval: June 4, 2004

Company: ISTA Pharmaceuticals, Inc.

Treatment for Glaucoma

Istalol is a once- a-day topical solution of timolol, a beta-blocking agent for the treatment of glaucoma.

Istalol ISTA Pharmaceuticals, Inc. - Treatment for Glaucoma
 
June 8
Menostar (estradiol transdermal system)

Date of Approval: June 8, 2004

Company: Berlex

Treatment for Prevention of Osteoporosis

Menostar is a clear, dime-sized, once-a-week patch that delivers low dose estrogen for post-menopausal osteoporosis prevention.

Menostar Berlex - Treatment for Osteoporosis Prevention
 
June 15
Zegerid (omeprazole and sodium bicarbonate) - formerly Rapinex

Date of Approval: June 15, 2004

Company: Santarus, Inc.

Treatment for Duodenal Ulcer, Gastroesophageal Reflux Disease, Gastric Ulcer, Erosive Esophagitis

Zegerid is an immediate-release formulation of omeprazole that contains sodium bicarbonate to protect omeprazole from acid degradation. Zegerid is approved for the treatment of duodenal ulcer, heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), and erosive esophagitis.

Zegerid Santarus, Inc. - Treatment for Heartburn/GERD, Erosive Esophagitis, Duodenal Ulcers
 
June 21
Codeprex (chlorpheniramine polistirex and codeine polistirex) Extended Release Suspension

Date of Approval: June 21, 2004

Company: Celltech Group plc

Treatment for Cough

Codeprex is the first codeine-based cough suppressant to provide 12-hour dosing and offers patients the convenience of less frequent dosing compared to other codeine cough suppressants, in particular by avoiding the need for middle of the night dosing.

Codeprex Celltech Group plc - Treatment for Cough
 
June 22
Mucinex D (guaifenesin and pseudoephedrine) Extended-Release Tablets

Date of Approval: June 22, 2004

Company: Adams Respiratory Therapeutics

Treatment for Cough and Nasal Congestion

Mucinex D is an expectorant and decongestant combination used for the relief of coughs and congestion associated with colds and allergies.

Mucinex D Adams Respiratory Therapeutics - Treatment for Cough and Congestion
 

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