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New Drug Approvals Archive - September 2004

See also: New Indications and Dosage Forms for September 2004

September 2004

Fluxid (famotidine) Orally Disintegrating Tablets

Date of Approval: September 24, 2004
Company: Schwarz Pharma, Inc.
Treatment for: Duodenal Ulcer, Gastric Ulcer, Gastroesophageal Reflux Disease, Zollinger-Ellison Syndrome

Marketing Status: Discontinued

Fluxid (famotidine orally disintegrating tablets) is a histamine H2-receptor antagonist indicated for the treatment of ulcers, gastroesophageal reflux disease and pathological hypersecretory conditions.

Palladone (hydromorphone hydrochloride) Extended Release Capsules

Date of Approval: September 24, 2004
Company: Purdue Pharma L.P.
Treatment for: Pain

Marketing Status: Discontinued

Palladone (hydromorphone hydrochloride) is an extended release opioid analgesic indicated for the management of moderate to severe pain in patients requiring continuous, around-the-clock analgesia.

OraDisc A (amlexanox) Mucoadhesive Patch

Date of Approval: September 29, 2004
Company: Access Pharmaceuticals, Inc.
Treatment for: Aphthous Ulcers

OraDisc A is a mucoadhesive patch which gradually erodes and releases the active drug amlexanox when applied to the inside of the mouth. OraDisc A is approved for the treatment of aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system.

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