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FDA Approvals 2004

Pentetate Calcium - pentetate calcium trisodium injection - radioactive contamination - Hamlen Pharmacueticals - approved 8/11/04
Pentetate Calcium is one of two injections approved by FDA in an effort to provide the American public with the best available protection against nuclear accidents and terrorist threats. This injection has been used for several decades as an investigational drug to treat patients in radiation contamination emergencies. After further findings, this injection has been approved for these indications. Until today, there had been no approved drug products for the treatment of internal contamination with plutonium, americium, or curium.

Pentetate Zinc- pentetate zinc trisodium injection - radioactive contamination - Hamlen Pharmacueticals - approved 8/11/04
Pentetate Zinc is one of two injections approved by FDA in an effort to provide the American public with the best available protection against nuclear accidents and terrorist threats. This injection has been used for several decades as an investigational drug to treat patients in radiation contamination emergencies. After further findings, this injection has been approved for these indications. Until today, there had been no approved drug products for the treatment of internal contamination with plutonium, americium, or curium.

Campral® acamprosate calcium - alcohol dependence - Lipha - approved 7/29/04
Campral is approved for treating alcohol dependent individuals seeking to continue to remain alcohol-free after they have stopped drinking. While its mechanism of action is not fully understood, Campral is thought to act on the brain pathways related to alcohol abuse, which continues to be a widespread and debilitating disorder. It is the first new drug approved for alcohol abuse in a decade and should be used as part of a comprehensive management program that includes psychosocial support.

NutreStore™ L-glutamine (SV) - short bowel syndrome - Nutritional Restart - approved 6/10/04
NutreStore is indicated to treat Short Bowel Syndrome (SBS) in combination with diet and other treatments. SBS is a group of problems affecting people who have had half or more of their small intestine removed - usually due to Crohn""s disease. The most common symptom of SBS is diarrhea. Because this condition is rare, this medicine was designated as an Orphan Drug.

Sanctura™ trospium chloride - overactive bladder - Indevus - approved 5/28/04
Sanctura is used for the treatment of overactive bladder (OAB) with symptoms of sudden need to urinate, unwanted urine leakage, and frequent urination.

Xifaxan™ rifaximin - traveler""s diarrhea - Salix - approved 5/25/04
Xifaxan is a nonsystemic (does not get into your bloodstream) antibiotic used to treat diarrhea caused by eating food or drinking fluids that have been contaminated with bacteria.

Octagam® immune globulin intravenous [human] - primary immune deficient diseases - Octapharma - approved 5/21/04
Octagam is approved to treat patients with primary immune deficiency. When people are born with a faulty immune system, they are said to have a primary immune deficiency. Only about 25,000 - 50,000 people suffer from the most serious forms of PI diseases in the United States, but experts believe that many more have milder disease that is not yet diagnosed. Octagam provides antibodies, which are proteins that help the body fight infections.

Vidaza™ azacitidine - myelodysplastic syndrome - Pharmion - approved 5/19/04
Vidaza is the first effective treatment for patients with Myelodysplastic Syndrome (MDS), which is a collection of rare conditions in which the bone marrow does not function normally and not enough normal blood cells are made. MDS can lead to leukemia, a type of cancer. This medicine helps restore normal growth and differentiation of bone marrow cells.

Tindamax™ tinidazole - infectious disease - Presutti Laboratories - approved 5/17/04
Tindamax is approved to treat three diseases caused by parasites: trichomoniasis, a sexually transmitted disease where both partners should be treated; giardiasis, an infection of the intestines; and amebiasis, an infection of the intestines that may spread throughout the body.

Vitrase® hyaluronidase, ovine - spreading agent to help disperse and absorb other drugs on the eye - Ista Pharmacueticals - approved 5/6/04
Vitrase is an injectable drug approved as an adjunct to (in combination with) other injected drugs to increase their absorption and dispersion. Hyaluronidase has been used most commonly in combination with local anesthetics in the setting of ophthalmic (eye) surgery.

Apokyn™ apomorphine HCl (P) - immobility in Parkinson""s disease - Bertek - approved 4/20/04
Apokyn is an injectable drug for treating Parkinson""s patients during episodes of "hypomobility," so-called "off periods" in which the patient becomes immobile or unable to perform activities of daily living. Apokyn was given priority review because injectable apomorphine is the first therapy approved to treat these episodes acutely (during the episode). Approximately 10 percent of Parkinson""s patients (112,000 patients) who are unresponsive to standard medications may benefit from Apokyn, as such it was also designated as an orphan product (a product treating a rare disease, affecting fewer than 200,000 people).

Apidra® insulin glulisine (S) - type 1 and 2 diabetes - Aventis - approved 4/16/04
Apidra is a rapid-acting synthetic insulin used to treat adults with diabetes for the control of high blood sugar, particularly for blood sugar spikes around meal times. Apidra starts working faster than regular insulin and does not work as long. It is used with a longer-acting insulin or by itself as an insulin pump therapy to maintain proper blood sugar control.

Human Secretin (PV) - stimulation of pancreatic and gastric secretion -ChiRhoClin - approved 4/9/04
Human secretin is a man-made hormone that is like the natural secretin made in the small intestine. It helps the pancreas and stomach produce secretions that aid in diagnosing problems such as a tumor and pancreatic exocrine dysfunction.

Ketek™ telithromycin (S) - antibiotic - Aventis - approved 4/1/04
Ketek is an antibiotic used to treat adults with certain respiratory (lung and sinus) infections caused by bacteria. Ketek kills many of the types of bacteria that can infect the lungs and sinuses, and has been found to treat these infections safely and effectively in clinical trials.

Sensipar™ cinacalcet HCl (P) - hyperparathyroidism - Amgen - approved 3/8/04
Sensipar is used to treat patients with high levels of parathyroid hormone in their blood due to chronic kidney disease that requires dialysis and patients with high levels of calcium in their blood due to cancer of the parathyroid gland. Sensipar lowers serum calcium.

Avastin™ bevacizumab - colorectal cancer - Genentech - approved 2/26/04
Avastin is a monoclonal antibody (an immune system protein) indicated for first-line treatment of patients with metastatic (spread to other parts of the body) colorectal cancer, in combination with standard chemotherapy drugs. Avastin is the first medicine approved to use a new type of "targeted" cancer therapy that chokes tumor growth by cutting off the blood supply to cancerous growths. This new mechanism helps spare healthy tissue and extend the life of the patient.

Erbitux™ cetuximab - colorectal cancer - Imclone and Bristol-Myers Squibb - approved 2/12/04
Erbitux was approved to treat patients with advanced colorectal cancer that has spread to other parts of the body. It is the first monoclonal antibody approved to treat this type of cancer. A monoclonal antibody is a substance produced in a lab that works like antibodies in the immune system, which specifically target foreign substances in the body. Using this mechanism, Erbitux is able to specifically target proteins involved in cancer growth.

Rhophylac® rho(D) immune globulin intravenous (human) - birth complication - ZLB Bioplasma - approved 2/12/04
Rhophylac is used in pregnant women to prevent birth complications for rhesus-negative women giving birth to rhesus-positive babies. Rhesus (Rh) factor is a protein found on the red blood cells of most people. If the baby has this protein and the mother does not, the mother""s immune system may fight against the baby""s blood, causing problems and possibly killing the fetus. This medicine helps suppress the immune system of mothers in this situation.

Alimta® pemetrexed disodium (PV) - pleural mesothelioma - Eli Lilly - approved 2/4/04
The first drug approved for the treatment of malignant pleural mesothelioma, a rare fatal cancer normally linked to asbestos exposure affecting about 2,000 additional people each year in the U.S. It is used in conjunction with other cancer drugs and extends patients"" life expectancy by about one quarter.

Spiriva® HandiHaler® tiotropium bromide (S) - COPD - Boehringer Ingelheim - approved 1/30/04
Spiriva HandiHaler is used for the treatment of breathing problems in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Spiriva is a maintenance bronchodilator. It helps to keep narrowed airways open.

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