Tuesday, January 8, 2008

Latest New Drug Approvals

Bystolic (nebivolol)
Date of Approval: December 17, 2007
Company: Mylan Laboratories Inc. and Forest Laboratories
Treatment for: Hypertension
Bystolic (nebivolol) is a once daily beta blocker approved for the treatment of hypertension.
Bystolic, a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension - December 18, 2007
FDA Issues Approvable Letter for Bystolic (nebivolol) for the Treatment of Hypertension - December 3, 2007
Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol - May 1, 2007
Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol - June 1, 2005
FDA Extends PDUFA Action Date for Nebivolol Tablets to May 31, 2005 - February 25, 2005
Mylan's NDA for Nebivolol Accepted for FDA Review - July 1, 2004
Mylan Submits New Drug Application for Nebivolol - May 5, 2004

Kuvan (sapropterin dihydrochloride) Tablets
Date of Approval: December 13, 2007
Company: BioMarin Pharmaceutical Inc.
Treatment for: Phenylketonuria
Kuvan is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase to metabolize phenylalanine (Phe). Kuvan is indicated for the treatment of phenylketonuria, an inherited metabolic disease caused by a deficiency of the enzyme phenylalanine hydroxylase.
BioMarin Announces FDA Approval for Kuvan - December 13, 2007
Kuvan Receives Priority Review Status from FDA - July 26, 2007
BioMarin Submits New Drug Application for U.S. Marketing Authorization of Kuvan for
Phenylketonuria (PKU) - May 24, 2007

Triesence (triamcinolone acetonide) Injectable Suspension
Date of Approval: November 29, 2007
Company: Alcon, Inc.
Treatment for: Use in Eye Surgery
Triesence is a synthetic corticosteroid indicated for visualization during vitrectomy and treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Alcon Receives FDA Approval of Triesence Injectable Triamcinolone Suspension for Use in Eye Surgery - December 3, 2007

Cymbalta (duloxetine) Delayed-Release Capsules
Date of Approval: August 3, 2004
Company: Eli Lilly and Company
Treatment for: Depression, Anxiety
Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Cymbalta was first approved in August 2004 for the acute treatment of major depressive disorder and has since been approved for the management of neuropathic pain associated with diabetic peripheral neuropathy and for the acute treatment of generalized anxiety disorder.New Indication Approved: November 28, 2007Treatment for: Maintenance Treatment of Major Depressive DisorderCymbalta is now also approved for the maintenance treatment of major depressive disorder (MDD) in adults.
FDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder - November 30, 2007
FDA Approves Cymbalta for Treatment of Generalized Anxiety Disorder - February 26, 2007
Cymbalta Eli Lilly and Company - Treatment for Depression - August 4, 2004
FDA Extends Action Date for Cymbalta for Continued Analysis of Already-Submitted Data - June 24, 2004

Mircera (methoxy polyethylene glycol-epoetin beta) Injection
Date of Approval: November 14, 2007
Company: Roche
Treatment for: Anemia Associated with Chronic Renal Failure
Mircera is an erythropoiesis-stimulating agent indicated for the treatment of anemia associated with chronic renal failure.
FDA Approves Mircera: First Renal Anemia Treatment in the US with Monthly Maintenance Dosing - November 15, 2007
Roche Receives Approvable Letter for Mircera in the United States - May 21, 2007
Roche Offers the FDA Additional Mircera Data - December 15, 2006
Roche Submits Application with FDA to Market C.E.R.A. - April 20, 2006

Combigan (brimonidine tartrate and timolol maleate) Ophthalmic Solution
Date of Approval: October 30, 2007
Company: Allergan Inc.
Treatment for: Intraocular Hypertension, Glaucoma
Combigan 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% - October 31, 2007
Allergan Announces FDA Issues Approvable Letter for Combigan 0.2%/0.5% - December 21, 2006

Tasigna (nilotinib) Capsules
Date of Approval: October 29, 2007
Company: Novartis
Treatment for: Chronic Myelogenous Leukemia
Tasigna is a kinase inhibitor indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib.
Tasigna Receives US Approval Providing New Hope to Chronic Myeloid Leukemia Patients with Resistance or Intolerance to Existing Therapies - October 29, 2007

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 - October 22, 2007
Genzyme Files for Approval of Sevelamer Carbonate for Patients on Dialysis - December 21, 2006

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 Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis - October 22, 2007

Ixempra (ixabepilone) Injection
Date of Approval: October 16, 2007
Company: Bristol-Myers Squibb
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 - October 17, 2007
FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone - June 19, 2007

Doribax (doripenem) Injection - formerly Doripenem
Date of Approval: October 12, 2007
Company: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatment for: Intraabdominal Infection, Urinary Tract Infection
Doribax 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 Complicated Intra-Abdominal and Complicated Urinary Tract Infections - October 15, 2007
New Drug Application Submitted for Investigational Antibiotic Doripenem - June 6, 2007
New Drug Application Submitted for Investigational Antibiotic Doripenem - December 15, 2006

Isentress (raltegravir) Tablets
Date of Approval: October 12, 2007
Company: Merck & Co., Inc.
Treatment for: HIV Infection
Isentress is an integrase inhibitor indicated for the treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents.
FDA Approves of Isentress (raltegravir) - October 12, 2007
Impending FDA Approval Decision on the First HIV Integrase Inhibitor Isentress Can Have Significant Impact for Patients - October 12, 2007
FDA Advisory Committee Unanimously Recommends Accelerated Approval of Isentress (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV - September 6, 2007
FDA Priority Review Granted for Isentress (raltegravir), Merck's Investigational Integrase Inhibitor for HIV - June 27, 2007

Afluria (influenza virus vaccine)
Date of Approval: September 28, 2007
Company: CSL Biotherapies
Treatment for: Influenza Prophylaxis
Afluria is an inactivated influenza virus vaccine, indicated for active immunization of persons ages 18 years and older against influenza disease.
CSL Biotherapies Announces FDA Marketing Approval of Afluria - September 28, 2007

Azor (amlodipine and olmesartan) Tablets - formerly amlodipine and olmesartan
Date of Approval: September 26, 2007
Company: Daiichi Sankyo, Inc.
Treatment for: Hypertension
Azor is a fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil. Azor is indicated for the treatment of hypertension.
Azor Receives FDA Approval for Treatment of High Blood Pressure - September 27, 2007
Daiichi Sankyo and Forest Laboratories Sign Letter of Intent for Co-Promotion of Azor - August 21, 2007
Daiichi Sankyo, Inc. Announces Filing of NDA for Amlodipine Besylate / Olmesartan Medoxomil Combination for the Treatment of Hypertension - November 28, 2006

Totect (dexrazoxane)
Date of Approval: September 6, 2007
Company: TopoTarget A/S
Treatment for: Anthracycline Extravasation
Totect is a topoisomerase inhibitor used as a detoxifying agent for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
Totect Approved in the United States - September 7, 2007
TopoTarget elaborates on the specific initiatives to obtain FDA approval of Totect - May 31, 2007

ACAM2000 (Smallpox (Vaccinia) Vaccine, Live)
Date of Approval: August 31, 2007
Company: Acambis Inc.
Treatment for: Smallpox Prophylaxis
ACAM2000 is live vaccinia virus smallpox vaccine intended for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 is the first biodefense vaccine to be approved as part of the US response to the 2001 bioterrorism attacks.
FDA Approves ACAM2000 Vaccine for Protection Against Smallpox - September 4, 2007

Somatuline Depot (lanreotide acetate) Injection - formerly Somatuline Autogel
Date of Approval: August 30, 2007
Company: Tercica, Inc.
Treatment for: Acromegaly
Somatuline Depot is a sustained-release injection formulation of lanreotide, a somatostatin analogue indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
Ipsen: Somatuline Depot Receives Marketing Approval in the United States for the Treatment of Acromegaly - August 31, 2007
FDA Accepts for Filing a New Drug Application (NDA) for Somatuline Autogel - January 15, 2007
Tercica Reports Somatuline Autogel NDA for Acromegaly Submitted to FDA - November 2, 2006

Evithrom (human thrombin)
Date of Approval: August 27, 2007
Company: Omrix Biopharmaceuticals, Ltd,
Treatment for: Bleeding
Evithrom is a highly purified human thrombin used as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.
FDA Approves Evithrom (human thrombin) for Topical Use in Surgery - August 28, 2007
Zingo (lidocaine hydrochloride monohydrate) Dermal PowderJect
Date of Approval: August 16, 2007
Company: Anesiva, Inc.
Treatment for: Local Anesthesia
Zingo is a needle-free, local anesthetic intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws, in children three to 18 years of age.
Anesiva Receives FDA Approval for Zingo, a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children - August 17, 2007
Endo Comments on Notices Received From Anesiva Regarding Zingo - April 10, 2007
Anesiva Announces FDA Acceptance for Filing of Zingo New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children - February 7, 2007
Anesiva Announces Filing of New Drug Application for Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children - November 27, 2006

Selzentry (maraviroc) Tablets
Date of Approval: August 6, 2007
Company: Pfizer Inc.
Treatment for: HIV Infection
Selzentry (maraviroc) is the first in a class of drugs known as CCR5 antagonists, approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood (viral load).
Pfizer's Selzentry (Maraviroc) Tablets, Novel Treatment for HIV, Approved by FDA - August 6, 2007
Pfizer Receives Approvable Letter From FDA For Maraviroc - June 21, 2007
FDA Advisory Committee Recommends Accelerated Approval of Pfizer’s Maraviroc for Treatment-Experienced Patients - April 25, 2007
Pfizer's Maraviroc to Receive Accelerated Regulatory Reviews in the U.S. and Europe - February 13, 2007More...

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