New Drug Approvals Archive

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May 2004

May 5

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.

Vitrase (hyaluronidase) FDA Approval History

May 10

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.

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

May 10

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.

LidoSite (lidocaine and Epinephrine ) FDA Approval History

May 10

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.

Enjuvia (synthetic conjugated estrogens, B) FDA Approval History

May 17

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.

Tindamax (tinidazole) FDA Approval History

May 18

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.

DepoDur (morphine sulfate) FDA Approval History

May 19

Vidaza (azacitidine) for Injectable Suspension

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

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

Vidaza (azacitidine) FDA Approval History

May 21

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.

Octagam (immune globulin intravenous (human)) FDA Approval History

May 25

Xifaxan (rifaximin) Tablets

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

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

Xifaxan (rifaximin) FDA Approval History

May 28

Sanctura (trospium chloride) Tablets

Date of Approval: May 28, 2004
Company: Indevus Pharmaceuticals, 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.

Sanctura (trospium chloride) FDA Approval History

January 30

Vidaza (azacitidine)

New Dosage Form Approved: January 26, 2007

Vidaza (azacitidine) FDA Approval History

April 30

Enjuvia (synthetic conjugated estrogens, B)

New Indication Approved: April 23, 2007

Enjuvia (synthetic conjugated estrogens, B) FDA Approval History

May 24

Tindamax (tinidazole)

New Indication Approved: May 21, 2007

Tindamax (tinidazole) FDA Approval History

August 6

Sanctura (trospium chloride)

New Dosage Form Approved: August 3, 2007

Sanctura (trospium chloride) FDA Approval History

August 21

Vidaza (azacitidine)

New Indication Approved: August 20, 2008

Vidaza (azacitidine) FDA Approval History

March 25

Xifaxan (rifaximin)

New Indication Approved: March 24, 2010

Xifaxan (rifaximin) FDA Approval History

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