New Drug Approvals Archive

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September 2004

September 7

Cymbalta (duloxetine)

New Indication Approved: September 3, 2004

Cymbalta (duloxetine) FDA Approval History

September 24

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 (famotidine) FDA Approval History

September 24

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 (hydromorphone hydrochloride) FDA Approval History

September 29

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 (amlexanox) FDA Approval History

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