New Drug Approvals Archive - October 2003

Jantoven (warfarin sodium) Tablets

Date of Approval: October 2, 2003
Company: Upsher-Smith
Treatment for: Thromboembolic Stroke Prophylaxis

Jantoven (warfarin) is an anticoagulant used to prevent heart attacks, strokes, and blood clots in veins and arteries. Jantoven is therapeutically equivalent to Coumadin.

• Jantoven Upsher-Smith - Treatment for Anticoagulant Therapy

Radiogardase (prussian blue insoluble) Capsules

Date of Approval: October 2, 2003
Company: HEYL Chemisch-pharmazeutische Fabrik GmbH
Treatment for: Radiation Emergency

Radiogardase (prussian blue) is used to treat people who have been contaminated with radioactive cesium or thallium, or non-radioactive thallium.

• Radiogardase HEYL Chemisch-pharmazeutische Fabrik GmbH - Treatment for Radiation Exposure

Estrasorb (estradiol topical ) Emulsion

Date of Approval: October 9, 2003
Company: Novovax
Treatment for: Postmenopausal Symptoms

Estrasorb is a topical estradiol emulsion approved for short-term use to reduce moderate to severe vasomotor symptoms (commonly known as "hot flashes") in menopausal women.

• Estrasorb Novovax - Treatment for Menopausal Vasomotor Symptoms

Namenda (memantine hydrochloride)

Date of Approval: October 16, 2003
Company: Allergan, Inc.
Treatment for: Alzheimer's Disease

Namenda is a low to moderate affinity NMDA (N-methyl-D-aspartate) receptor antagonist indicated for treatment of moderate to severe dementia of the Alzheimer’s type.

• Namenda Forest Laboratories Inc. - Treatment for Alzheimer’s Disease

Elestat (epinastine hydrochloride) Ophthalmic Solution, 0.05%

Date of Approval: October 16, 2003
Company: Allergan, Inc.
Treatment for: Allergic Conjunctivitis

Elestat (epinastine) is topical H1-receptor antagonist used for the prevention of itching associated with allergic conjunctivitis.

• Elestat Allergan, Inc. - Treatment for Prevention of Itching associated with Allergic Conjunctivitis

Lexiva (fosamprenavir calcium)

Date of Approval: October 20, 2003
Company: ViiV Healthcare
Treatment for: HIV Infection

Lexiva (fosamprenavir) is a protease inhibitor (PI) for the treatment of HIV infection in adults in combination with other antiretroviral medications. Lexiva offers flexible dosing with no food or water restrictions.

• Lexiva GlaxoSmithKline - Treatment for HIV Infection

Raptiva (efalizumab) Injection

Date of Approval: October 27, 2003
Company: Genentech Inc.
Treatment for: Psoriasis

Raptiva (efalizumab) is a monoclonal antibody indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis.

• Raptiva Genentech Inc. - Treatment for Psoriasis

Risperdal (risperidone)

New Dosage Form Approved: October 29, 2003

• Risperdal Consta Approved for Schizophrenia

Namenda (memantine hydrochloride)

New Dosage Form Approved: June 21, 2010

• Forest and Merz Announce FDA Approval of Namenda XR for the Treatment of Moderate to Severe Dementia of the Alzheimer's Type