New Drug Approvals Archive - October 2007
See also: New Indications and Dosage Forms for October 2007
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.
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.
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.
Voltaren Gel (diclofenac sodium) Topical Gel
Date of Approval: October 17, 2007
Company: GlaxoSmithKline Consumer Healthcare
Treatment for: Osteoarthritis
Voltaren Gel (diclofenac sodium) is a topical non-steroidal anti-inflammatory (NSAID) medication indicated for the temporary relief of joint pain due to osteoarthritis.
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.
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).
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.
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