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New Drug Approvals Archive - May 2004

May 2004

Vitrase (hyaluronidase) for Injection

Date of Approval: May 5, 2004
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Hypodermoclysis, Subcutaneous Urography

Vitrase is a preparation of purified ovine testicular hyaluronidase indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Read more: Vitrase (hyaluronidase) FDA Approval History

HalfLytely and Bisacodyl Tablets (bisacodyl and polyethylene glycol (PEG) 3350 with electrolytes) Bowel Prep Kit

Date of Approval: May 10, 2004
Company: Braintree Laboratories, Inc.
Treatment for: Bowel Preparation

HalfLytely and Bisacodyl Tablet Bowel Prep Kit is a combination of PEG- 3350, an osmotic laxative and bisacodyl, a stimulant laxative, indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Read more: HalfLytely and Bisacodyl Tablets (bisacodyl and polyethylene glycol (PEG) 3350 with electrolytes) FDA Approval History

LidoSite (lidocaine and Epinephrine ) Topical System

Date of Approval: May 10, 2004
Company: Vyteris, Inc.
Treatment for: Local Anesthesia

LidoSite (lidocaine and epinephrine) is an iontophoretic delivery system providing local analgesia prior to the administration of superficial dermatological procedures.

Read more: LidoSite (lidocaine and Epinephrine ) FDA Approval History

Enjuvia (synthetic conjugated estrogens, B) Tablets

Date of Approval: May 10, 2004
Company: Duramed Pharmaceuticals
Treatment for: Postmenopausal Symptoms, Atrophic Vaginitis

Enjuvia (synthetic conjugated estrogens, B) is a synthetic conjugated estrogen product indicated for the treatment of menopausal vasomotor symptoms and for the treatment of vaginal dryness and atrophy.

Read more: Enjuvia (synthetic conjugated estrogens, B) FDA Approval History

Tindamax (tinidazole) Tablets

Date of Approval: May 17, 2004
Company: Presutti Laboratories
Treatment for: Trichomoniasis, Giardiasis, Bacterial Vaginosis

Tindamax (tinidazole) is a synthetic nitroimidazole antiprotozoal agent for the treatment of trichomoniasis, giardiasis, amebiasis, and bacterial vaginosis in nonpregnant women.

Read more: Tindamax (tinidazole) FDA Approval History

DepoDur (morphine sulfate) extended-release liposome Injection

Date of Approval: May 18, 2004
Company: SkyePharma PLC and Endo Pharmaceuticals
Treatment for: Pain

DepoDur (morphine sulfate extended-release liposome injection) is an opiate for the treatment of pain following major surgery.

Read more: DepoDur (morphine sulfate) FDA Approval History

Vidaza (azacitidine) for Injectable Suspension

Date of Approval: May 19, 2004
Company: Pharmion Corporation
Treatment for: Myelodysplastic Disease

Vidaza (azacitidine) is an antineoplastic agent for the treatment of patients with myelodysplastic syndromes.

Read more: Vidaza (azacitidine) FDA Approval History

Octagam (immune globulin intravenous (human)) Injection

Date of Approval: May 21, 2004
Company: Octapharma AG
Treatment for: Primary Immunodeficiency Syndrome

Octagam (immune globulin intravenous (human)) is a ready-to-use immunoglobulin intravenous (IGIV) product indicated for the treatment of primary immunodeficiency diseases.

Read more: Octagam (immune globulin intravenous (human)) FDA Approval History

Xifaxan (rifaximin) Tablets

Date of Approval: May 25, 2004
Company: Salix Pharmaceuticals, Ltd
Treatment for: Traveler's Diarrhea, Hepatic Encephalopathy, Irritable Bowel Syndrome

Xifaxan (rifaximin) is a nonsystemic antibiotic indicated for the treatment of patients with traveler's diarrhea caused by noninvasive strains of Escherichia coli, to reduce the risk of recurrence of hepatic encephalopathy in patients with advanced liver disease, and for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Read more: Xifaxan (rifaximin) FDA Approval History

Sanctura (trospium chloride) Tablets

Date of Approval: May 28, 2004
Company: Allergan, Inc.
Treatment for: Urinary Frequency, Urinary Incontinence

Sanctura (trospium chloride) is an antispasmodic, antimuscarinic agent indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Read more: Sanctura (trospium chloride) FDA Approval History

Tindamax (tinidazole)

New Indication Approved: May 21, 2007

Read more: Tindamax (tinidazole) FDA Approval History

Sanctura (trospium chloride)

New Dosage Form Approved: August 3, 2007

Read more: Sanctura (trospium chloride) FDA Approval History

New Drug Approvals Archive