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New Drug Approvals Archive - May 2004

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 ISTA Pharmaceuticals, Inc. - Treatment for Spreading Agent 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 Braintree Laboratories, Inc. - Treatment for Colonoscopy Preparation 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 Vyteris, Inc. - Treatment for Localized Pain 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 Duramed Pharmaceuticals - Treatment for Menopausal Vasomotor Symptoms 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 Presutti Laboratories - Treatment for Infections 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 SkyePharma PLC and Endo Pharmaceuticals - Treatment for Post-Surgical Pain Relief 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 Disease Vidaza (azacitidine) is an antineoplastic agent for the treatment of patients with myelodysplastic syndromes. FDA Approves Vidaza for Myelodysplastic Syndromes (MDS) 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 Octapharma AG - Treatment for 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, 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). Xifaxan Salix Pharmaceuticals, Ltd - Treatment for Travelers’ Diarrhea Xifaxan (rifaximin) FDA Approval History
May 28	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. Sanctura Indevus Pharmaceuticals, Inc. - Treatment for Overactive Bladder Sanctura (trospium chloride) FDA Approval History
January 30	Vidaza (azacitidine) New Dosage Form Approved: January 26, 2007 Pharmion Corporation Announces FDA Approval of Vidaza NDA Supplement for IV Administration Vidaza (azacitidine) FDA Approval History
April 30	Enjuvia (synthetic conjugated estrogens, B) New Indication Approved: April 23, 2007 Duramed's Enjuvia (Synthetic Conjugated Estrogens, B) TabletsReceives Two New FDA Approvals Enjuvia (synthetic conjugated estrogens, B) FDA Approval History
May 24	Tindamax (tinidazole) New Indication Approved: May 21, 2007 FDA Approves Tindamax for Bacterial Vaginosis Tindamax (tinidazole) FDA Approval History
August 6	Sanctura (trospium chloride) New Dosage Form Approved: August 3, 2007 Indevus Announces FDA Approval of Sanctura XR Sanctura (trospium chloride) FDA Approval History
August 21	Vidaza (azacitidine) New Indication Approved: August 20, 2008 Vidaza Receives Expanded FDA Approval to Include Overall Survival in Higher-Risk MDS Vidaza (azacitidine) FDA Approval History
March 25	Xifaxan (rifaximin) New Indication Approved: March 24, 2010 FDA Approves New Use of Xifaxan for Patients with Liver Disease Xifaxan (rifaximin) FDA Approval History
May 27	Xifaxan (rifaximin) New Indication Approved: May 27, 2015 FDA Approves Xifaxan (rifaximin) for the Treatment of IBS-D (Irritable Bowel Syndrome with Diarrhea) Xifaxan (rifaximin) FDA Approval History

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