New Drug Approvals Archive - October 2007

Isentress (raltegravir) Tablets

Date of Approval: October 12, 2007
Company: Merck & Co., Inc.
Treatment for: HIV Infection

Isentress (raltegravir) is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

• FDA Approves of Isentress (raltegravir)
• Isentress (raltegravir) FDA Approval History

Doribax (doripenem) Injection

Date of Approval: October 12, 2007
Company: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatment for: Intraabdominal Infection, Urinary Tract Infection

Marketing Status: Discontinued

Doribax (doripenem) is a penem antibacterial indicated for the treatment of complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis.

• FDA Approves Doribax for the Treatment of ComplicatedIntra-Abdominal and Complicated Urinary Tract Infections
• Doribax (doripenem) FDA Approval History

Ixempra (ixabepilone) Injection

Date of Approval: October 16, 2007
Company: R-Pharm US
Treatment for: Breast Cancer

Ixempra (ixabepilone) is a semisynthetic analog of epothilone B indicated for the treatment of patients with metastatic or locally advanced breast cancer.

• FDA Approves Ixempra (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
• Ixempra (ixabepilone) FDA Approval History

Voltaren Gel (diclofenac sodium) Topical Gel

Date of Approval: October 17, 2007
Company: Novartis AG
Treatment for: Osteoarthritis

Voltaren Gel (diclofenac sodium) is a topical gel non-steroidal anti-inflammatory (NSAID) medication indicated for the pain of osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.

• Voltaren Gel Receives US Regulatory Approval as the First ApprovedTopical Prescription Treatment for Pain Associated withOsteoarthritis
• Voltaren Gel (diclofenac sodium) FDA Approval History

Renvela (sevelamer carbonate) Tablets

Date of Approval: October 19, 2007
Company: Genzyme Corporation
Treatment for: Hyperphosphatemia of Renal Failure

Renvela (sevelamer carbonate) is a calcium-free, metal-free, non-absorbed phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

• FDA Approves Genzyme's Renvela for Dialysis Patients
• Renvela (sevelamer carbonate) FDA Approval History

Tasigna (nilotinib) Capsules

Date of Approval: October 29, 2007
Company: Novartis
Treatment for: Chronic Myelogenous Leukemia

Tasigna (nilotinib) is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML).

• Tasigna Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients with Resistance or Intolerance to Existing Therapies
• Tasigna (nilotinib) FDA Approval History

Combigan (brimonidine tartrate and timolol maleate) Ophthalmic Solution

Date of Approval: October 30, 2007
Company: Allergan Inc.
Treatment for: Intraocular Hypertension, Glaucoma

Combigan (brimonidine tartrate and timolol maleate) is an alpha adrenergic receptor agonist and beta adrenergic receptor inhibitor combination ophthalmic solution for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP.

• Allergan, Inc. Receives FDA Approval for Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
• Combigan (brimonidine tartrate and timolol maleate) FDA Approval History