New Drug Approvals Archive

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October 2003

October 2

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.

October 2

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.

October 9

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.

October 16

Namenda (memantine hydrochloride)

Date of Approval: October 16, 2003
Company: Forest Laboratories 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.

October 16

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.

October 20

Lexiva (fosamprenavir calcium)

Date of Approval: October 20, 2003
Company: GlaxoSmithKline
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.

October 27

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.

October 29

Risperdal (risperidone)

New Dosage Form Approved: October 29, 2003

June 22

Namenda (memantine hydrochloride)

New Dosage Form Approved: June 21, 2010

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