2000 MEDS

NEW DRUGS 2000

ACTIMMUNE (New indication) This drug which is interferon gamma 1b has been available since 1990 for the treatment of infections associated with severe granulatomous disease.

ACTONEL (Risendronate) Procter & Gamble - Actonel is indicated in the treatment of degenerative bone disease in postmenopausal women. This drug can significantly reduce the incidence of both hip and vertebral fractures. It is similar in pharmacology to Fosamax but may have a lower incidence of gastrointestinal side effects.

ANDROGEL (Testosterone gel) This new product for men is applied topically is indicated for the treatment of reduced libido, impotence, loss of energy and muusculature, and decreased bone density. When applied once daily 87% of hypogonadal men achieved normal testosterone levels and sexual desire, bone mineral density and lean body weight both increased. Androgel for male impotence.

ASTELIN (Azelastine hydrochloride) Nasal Spray, Rx Wallace Laboratories NDA 20-114/S-005 5/30/00 Astelin Indications: Treatment of the symptoms of seasonal allergic sneezing, and nasal pruritus in adults and children 5 years and older (NOTE: Previously approved for 12 years and older

ATACAND (Candesartan cilexetil) 4, 8, 16, and 32 mg Tablets Astra Merck NDA 20-838 6/4/98 Atacand Indication: for the treatment of hypertension. It may be used
alone or in combination with other antihypertensive agents.

ATRIDOX (Doxycycline hyclate, 10.0%) in the Atrigel Delivery System for Controlled Release in Subgingival Application [63.3% N-methyl-2-pyrrolidone and 36.7% poly (DL-lactide)], Rx Atrix Laboratories NDA 50-751 9/4/98 Atridox Indication: Provides for the use of Atridox for the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing.

AVAPRO HCT Tablets, 75/12.5 & 150/12.5 Bristol-Myers Squibb NDA 20-758/S-003 8/31/98

AZACTAM (Aztreonam injection), Rx Bristol-Myers Squibb NDA 50-632/SE1-010 12/24/98

BETAPACE AF (Sotalol hydrochloride) Tablets, Rx Berlex Laboratories NDA 21-151 2/22/00 Betapace AF Indication: Maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because Betapace AF can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB/AFL that is easily reversed should usually not be given Betapace AF.

CAFCIT (Caffeine Citrate) Roxane - Cafcit has been approved for the treatment of apnea of prematurity. This drug stimulates respiration in infants whose lungs are not fully developed. It is used to reduce the occurrence of episodes of cessation or reduced respiration (apnea) in these babies which will hopefully lower the need for supplemental oxygen. On day 2 after birth, the incidence of apnea in Cafcit treated infants was 75% compared with 92% in placebo treated infants.

EVOXAC (Cevimeline) Snowbird Pharmaceuticals - this new agent is the second drug to win FDA approval for the salivary deficiency experienced by patients with Sjorgren's Syndrome. It acts by stimulating muscarinic receptors which results in secretions from exocrine glands such as the salivary glands. Side effects include: Headache (14%), nausea (14%), running of nose (11%), respiratory tract infection (11%) and increased sweating (19%)

EXELON (Rivastigmine) Novartis - Exelon, which has been available in Europe for some time, is indicated for the treatment of Alzheimer's disease. The mechanism of action is similar to Aricept and Cognex, both of which act to increase brain levels of acetylcholine, a critical brain neurotransmitter. After 26 weeks of therapy, 81% of patient either showed improvement in cognitive function or had a slower decrease in deterioration than did those taking a similar looking placebo (dummy).

FLOLAN (Epoprostenol sodium) Injection, Rx Glaxo Wellcome NDA 20-444/S-003 4/14/00 Flolan Indication: Long-term intravenous treatment of pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III & Class IV patients who do not respond to conventional therapy

GEMZAR (Gemcitabine HCl) for Injection, Rx Eli Lilly NDA 20-509
SE1-005 8/26 Gemzar Indications: For use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer.

HYCAMTIN (Topotecan hydrochloride) for Injection, Rx SmithKline Beecham Pharmaceuticals NDA 20-671/S-004 11/30/98 Hycamtin Indication: This supplemental new drug application provides for the useof Hycamtin in the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy.

LOTRONEX (Alosetron HCl) Tablets, Rx GlaxoWellcome, Inc. NDA 21-107 2/9/00 OTRONEX Indication: is indicated for the treatment of irritable bowel syndrome (IBS) in female patients whose predominant bowel symptom is diarrhea. The safety and effectiveness in men have not been established

MOBIC (Meloxicam)
this new drug is similar in action to Celebrex and Vioxx and is indicated for the treatment of pain associated with osteoarthritis. Side effects include: gastrointestinal upset, nausea.

MYLOTARG (Gemtuzumab zogamicin)
Wyeth-Ayerst - Myelotarg is novel medication indicated for the treatment of relapsed adult acute myelocytic leukemia. This novel drug combines a specific antibody, CD33, with a chemotherapeutic drug (zogamicin). Specifically, the antibody attaches to the CD33 antigen found on leukemic cells which then delivers a toxic dose of zogamicin to the cancer cells. In trials, 26% of patients who no longer responded to conventional chemotherapy went into remission after Mylotarg. The relatively specific targeting of the leukemic cells reduces the toxicity to other non-target cells and reduces side effects significantly.

PACIS BCG, Live Pacis is a form of Bacillus Calmette-Guerin (BCG) which has been approved for the immunotherapy of carcinoma in situ of the urinary bladder. The recommended course of therapy is a single dose given once weekly for six weeks. Manufacturer BioChem Pharma, USA distributor UroCo.

PRECEDEX (De xmedetomidine) This is a new agent given intravenously for t he postoperative use in an intensive care environment. It produces bo th sediation and analgesia without any accompanying respiratory depre ssion.

PREVNAR (Pneumococcal 7-valent conjugate vaccine) Prenvar is indicated for the prevention of pneumococcal respiratory tract infections in children under 5 years and immunocomprised individuals. The vaccine was found to be 100% effective in preventing infections caused by 7 of the pneumococcal serotypes which produce 80% of acquired pneumococcal pneumonia in those at risk.

PROTONIX (Pantoprazole) This new oral drug is indicated for the short term treatment of gastroesophageal reflux which can lead to erosive esophagitis. This medication which will be available in the 2nd quarter of 2000. It is similar in pharmacology to Prilosec and Prevacid thus its only advantage over the other two drugs will be if it is less expensive.

REFACTO This is a genetically altered factor VIII whi ch is used to prevent bleeding episodes in patients with hemophilia A who are undergoing surgery. It is also indicated for short-term ro utine prevention and reduction of spontaneous bleeding.

TARGRETIN (Bexarotene) capsules, 75 mg ligand Pharmaceuticals NDA 21-055 12/29/99 Targretin Indication: Targretin (bexarotene) capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.

TRILEPTAL (Oxcarbazepine) This newly released antiepileptic drug (AED)is indicated for the treatment of partial siezures in adults and as adjunctive therapy along with other AEDS for children aged 4-14 years. In one clinical trial, 12% of patients who had failed on other therapies became seizure-free on Trileptal and a decrease in seizure frequency occurred in 50% of the others treated. Side effects include: dizziness, fatigue, dizziness and blurred vision. A small % experienced low serum sodium levels thus serum sodium levels need to be determined periodically while on Trileptal therapy. Approximately 1/3 of those allergic to carbamazepine (Tegretol) will also be allergic to Trileptal.

VIADUR (Leuprolide acetate implant), Rx ALZA Corporation NDA 21-088/S0 3/3/00 Viadur Indication: palliative treatment of advanced prostate cancer

ZEMPLAR (Paricalcitol)- Abbott - Zemplar has been approved for the treatment of hyperparathyroidism. Zemplar is a synthetic vitamin D analogue which suppresses parathyroid hormone production with a minimal effect on calcium and phosphorous. side effects are rare and consist of nausea, vomiting, and diarrhea.

ZONEGRAN (Zonisamide) This new drug has been approved for adjunctive treatment of partial (focal) epilepsy in adults. There was a 25% reduction in seizure frequency . The major side effect is sedation (17%). An unusual side effect is that this drug produces kidney stones in 4% of those taking it and a high fluid intake is recommended to prevent this side effect. Zonegran for partial seizures in adults. Zonegran for partial seizures.

ZYVOX (Linezolid) Tablets, I.V., & Oral Suspension, 400 & 600 mg Tablets; I.V. 200 mg/100 mL, 400 mg/200 mL, & 600 mg/300 mL bags; Oral Suspension, 100 mg/5 mL Pharmacia & Upjohn NDA 21-130, 31, 32 4/18/00 Zyvox Indications: The treatment of adult patients with vancomycin-resistant Enterococcus faecium infections, nosocomial pneumonia, complicated and uncomplicated skin and skin structure infections, and community-acquired pneumonia.