New Drug Approvals: September 2004

Company: Schering-Plough Corporation

Treatment for Allergy Symptoms in Children

Date of Approval: September 24, 2004

Company: Schwarz Pharma, Inc.

Treatment for Duodenal Ulcer, Gastric Ulcer, Gastroesophageal Reflux Disease, Zollinger-Ellison Syndrome

Fluxid is a disintegrating tablet dosage form of famotidine indicated for the treatment of ulcers, gastroesophageal reflux disease and pathological hypersecretory conditions.

Date of Approval: December 31, 1969

Company: Purdue Pharma L.P.

Treatment for Moderate to Severe Pain

Palladone Capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock opioid analgesia with a high potency opioid for an extended period of time generally weeks to months or longer.

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.