New Drug Approvals Archive - September 2004

Cymbalta (duloxetine)

New Indication Approved: September 3, 2004

• FDA Approves Cymbalta for Neuropathic Pain Associated With Diabetes

Cymbalta (duloxetine) FDA Approval History

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

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

• Fluxid Schwarz Pharma, Inc. - Treatment for Ulcers and other Gastrointestinal Conditions

Fluxid (famotidine) FDA Approval History

Palladone (hydromorphone hydrochloride) Extended Release Capsules

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

Palladone (hydromorphone hydrochloride) is an extended release opioid analgesic 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.

• Palladone Purdue Pharma L.P. - Treatment for Moderate to Severe Pain

Palladone (hydromorphone hydrochloride) FDA Approval History

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.

• OraDisc A Access Pharmaceuticals, Inc. - Treatment for Aphthous Ulcers

OraDisc A (amlexanox) FDA Approval History