New Drug Approvals Archive

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June 2004

June 4

Istalol (timolol maleate ophthalmic) Solution

Date of Approval: June 4, 2004
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Glaucoma

Istalol (timolol maleate ophthalmic solution) is a beta-blocking agent for the treatment of glaucoma.

Istalol (timolol maleate ophthalmic) FDA Approval History

June 8

Menostar (estradiol transdermal system)

Date of Approval: June 8, 2004
Company: Berlex
Treatment for: Prevention of Osteoporosis

Menostar (estradiol transdermal system) is an estrogen patch for the prevention of postmenopausal osteoporosis.

Menostar (estradiol transdermal system) FDA Approval History

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 (omeprazole and sodium bicarbonate) is proton-pump inhibitor and antacid combination for the treatment of duodenal ulcer, heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), and erosive esophagitis.

Zegerid (omeprazole and sodium bicarbonate) FDA Approval History

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 (chlorpheniramine polistirex and codeine polistirex) is an antihistamine and cough suppressant combination for the treatment of cough.

Codeprex (chlorpheniramine polistirex and codeine polistirex) FDA Approval History

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 (guaifenesin and pseudoephedrine) is an expectorant and decongestant combination used for the relief of coughs and congestion associated with colds and allergies.

Mucinex D (guaifenesin and pseudoephedrine) FDA Approval History

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