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NEW DRUGS 1999
AGENERASE (Amprenavir)This new protease inhibitor is the most recent
addition to the drugs used to combat the HIV virus (AIDS-producing). It major advantage is
that it can be give two times a day. Thus, if taken with other AIDS drugs also given two
times a day, patient adherance to therapy should be improved. Adverse effects include
diarrhea, vomiting and perioral numbness. Occasionally, a severe life-threatning rash may
occur in 1% of patients treated with Agenerase. The cost is between Crixivan and Viracept,
the other two more commonly used protease inhibitors.
ANTAGON (Ganirelix)This injectable drug is used to
increase the liklihood of successful multiple oocyte formation and harvesting in women
undergoing in vitro fertilization. It acts by suppressing the surge in lutenizing hormone
(LH) associated with stimulation of gonadotropin-releasing hormone. This surge results in
the expulsion of the oocyte from the ovary which is not wanted.
AREDIA
(Pamidronate disodium for injection),
Rx Novartis Pharmaceuticals Corporation NDA 20-927 9/22/98 Aredia Indication: This
is not a new indication. This NDA provided the results of the one-year extension period of
the two Phase 3 studies that were submitted to support the approval of the NDA
20-036/S-011 in HFD-510. NDA 20-036/S-011 provided for the use of Aredia in conjunction
with standard antineoplastic therapy for the treatment of osteolytic bone metastases of
breast cancer.
AVANDIA
(Rosiglitazone) Tablets,
2, 4, and 8 mg, Rx SmithKline Beecham Pharmaceuticals. NDA 21-071 5/25/99 Avandia
Indications: Used as an adjunct to diet and exercise to improve glycemic control in
patients with Type 2 diabetes mellitus as monotherapy or in combination with metformin.
BUSULFEX
(Busulfan) Injection,
intravenous, Rx Orphan Medical, Inc. NDA 20-954 2/4/99 BUSULFEX Indication: For use
in combination with cyclophosphamide as a conditioning regimen prior to allogeneic
hematopoietic progenitor cell transplantation for chronic myelogenous leukemia
CAMPTOSAR (iIinotecan
hydrochlorise injection) 20 mg/mL Intravenous, Rx Pharmacia & Upjohn NDA
20-571/S-008 10/22/98 Camptosar: Treatment of patients with metastatic carcinoma of the
colon or rectum whose disease has recurred or progressed following 5-FU-based therapy.
CELEBREX CAPSULES, Rx G.
D. Searle & Co. NDA 21-156 & 20-998/S007 12/23/99 Celebrex Indication: To reduce
the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an
adjunct to usual care (e.g., endoscopic surveillance , surgery).
CHEWABLE DISPERSIBLE TABLETS,
Rx Glaxo Wellcome NDA 20-241/S-003 & NDA 20-764/S-001 12/14/98 Lamictal
Indications: These efficacy supplements provide for the use of Lamictal as conversion to
monotherapy in adults with partial seizures who are receiving treatment with a single
enzyme-inducing antiepileptic drug (EIAED).
COMTAN (Entacapone)
Comtan is used for the treatment of Parkinson's Disease. It acts by inhibiting the enzyme
catechol-O-methyltransferase which metabolizes l-DOPA. Inhibition of this enzyme will
increase the blood levels of levodopa. This may lead to more constant dopaminergic
stimulation in the brain and better control of the disease. It is likely that
co-administration with l-DOPA will require a reduction in l-dopa dose.
CLIMARA (Estradiol transdermal
system), 0.025mg/day, 0.05mg/day, 0.075mg/day, & 0.1mg/day, Rx Berlex
Laboratories, Inc. NDA 20-994 3/8/99 Climara Indication: prevention of
postmenopausal osteoporosis (loss of bone mass)
ELLENCE (Epirubicin)
This new drug indicated for the treatment of breast cancer which has lymph node
involvement. Clinical studies compared the long term result of epirubicin in combination
with fluorouracil and cyclophosphamide to the previous standard
cyclophosphamide-methotrexate-fluorouracil (CMF). The regimen containing Ellence produced
a significantly greater relapse-free 5-year survival rate of 62% vs. 53% observed with the
CMF protocol. However, there were also significantly more side effects, particularly
cardic toxicity which could result in congestive heart failure.
ETHYOL (Amifostine) Injection, 500mg (amifostine anhydrous base), Rx US
Bioscience NDA 20-221/S-012
6/24/99 Ethyol Indication: To reduce the incidence of moderate to severe xerostomia in
patients undergoing post-ooperative radiation treatment for head and neck cancer, where
the radiation port includes a substantial portion of the parotid glands (see Clinical
Studies).
EXEMESTANE (Aromasin)
This new drug is indicated for metastatic breast cancer in postmenopausal women. It acts
by inhibiting the enzyme, aromatase. There are two other similar drugs available with that
pharmacology, Arimidex and Femara. It may have and advantage in producing more complete
estrogen depletion than the other drugs. Famvir
(famciclovir) Tablets, 125mg, 250mg, & 500mg SmithKline Beecham NDA
20-363/S-010/S-014/S-016 6/12/98 Famvir Indication: for the treatment of recurrent
mucocutaneous herpes simplex infections in HIV-infected patient
FRAGMIN (Dalteparin sodium injection),
Rx Pharmacia and Upjohn NDA 20-287/S-008 3/30/99 Fragmin Indication: Prophylaxis of
deep vein thrombosis (DVT), which may lead to pulmonary embolism, in patient undergoing
hip replacement surgery.
INTEGRILIN (Eptifibatide),
20 mg/10 ml and 75 mg/ 100 ml, Injection COR Therapeutics NDA 20-718 5/18 Integrilin
Indications: 1. For the treatment of patients with acute coronary syndrome (UA/NQMI),
including patients who are to be managed medically and those undergoing percutaneous
coronary intervention (PCI). In this setting, INTEGRILIN has been shown to decrease the
rate of a combined endpoint of death or new myocardial infarction. 2. For the treatment of
patients undergoing PCI. In this setting, INTEGRILIN has been shown to decrease the rate
of a combined endpont of death, new myocardial infarction, or need for urgent intervention
KEPPRA (Levetiracetam)
UCB Pharma- this is a new addition to antiepileptic drugs used to treat seizure disorders.
It is indicated for partial onset seizures where 35-40% of patients responded with a 50%
reduction of episodes compared with 7% on placebo. Side effects include: weakness (15%),
change in behavior (13%), motor coordination difficulties (4%) drowsiness (2%), and minor
decreases in white blood cells (3%). Note: Keppra will not be available in pharmacies
until April-May 2000 and is not available inder a compassionate release program.
LAMICTAL
(Lamotrigine) Tablets & LAMICTAL (Lamotrigine)
LEVULAN
This innovative drug was approved for use as photodynamic treatment of actinic keratosis,
a premalignant shin condition found in aging adults. Following the application of Levulan
as a topical solution, and blue light there was a 86% clearing of lesions after one
application and a 94% clearing after a second application.
LIDODERM (Lidocaine patch 5%)
Lidoderm is indicated for the relief of pain associated with postherpetic neuralgia, a
complication of shingles. When applied topically over the area of pain, significant pain
relief occurred lasting for 8-12 hours. Side effects of local erythem and edema at the
application site were generally mild and transient. Available Sept.-Oct.,1999.
LOVENOX
(Enoxaparin sodium) Injection,
Subcutaneous (SC),
Rx or OTC: Rx Rhone-Poulenc Rorer Pharmaceuticals NDA 20-164 12/31/98 Lovenox
Indications: (1) the inpatient treatment of acute deep vein thrombosis with and without
pulmonary embolism, when administered in conjunction with warfarin sodium, and (2) the
outpatients treatment of acute deep vein thrombosis without pulmonary embolism when
administered in conjunction with warfarin sodium
ONTAK (Denileukin diftitox)
This drug has been approved for the treatnent of persistant or recurrent T-cell lymphoma
whose cells express an IL-2 recerptor. Ontak is a fusion protein which adheres to the
interleukin-2 receptor on the malignant cell thus affecting producing cell death.
PACERONE
(Amiodarone Hydrochloride) Tablets,
200mg Upsher-Smith Laboratories, Inc. ANDA 75-135 4/30/98
PANRETIN (Alitretinoin) Gel ,
0.1%, Rx Ligand Pharmaceuticals NDA 20-886 2/2/99 Panretin Indication: Treatment of
cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.
PENLAC (Ciclopirox)
Recently the FDA approved this innovative topical preparation for the treatment of
fingernail and toenail fungasl infections. Penlac must be applied daily for 7 days at
which time the lacquer is removed and the applications repeated. It may take up to 48
weeks to completely eradicate the fungus but the topical administration does avoid the
side effects of systemic antifungal agents.
PLETAL (Cilostazol)
This drug is indicated for the treatment of intermittent claudication, a painful condition
where the legs do not get enough blood supply for brief periods of time. The mechanism of
action may be to affect platelet aggregation thus making it less likely that blood flow
will be interrupted and that intermittent claudication will occur. It will also produce
dilation of small arteries which may also help to maintain blood flow. Pletal is
contraindicated in congestive heart failure. Headache is the most common side effect,
followed by diarrhea.
RAPAMUNE (Sirolimus)
This drug is indicated for the prevention of transplant rejection. When used together with
cyclosporin and corticosteroids, the incidence of rejection was 15-19% compared with 32%
for a similar treatment using azathioprine (Immuran). Side effects include: anemia,
decreased white blood cells (leukopenia), low blod potassium, fever, diarrhea, and a
decreased blood platelet count (thrombocytopenia).
RELENZA (Zanamivir)
This drug is the first drug approved for the treatment of influenza A and B. It is inhaled
and for maximum effectiveness, it must be used in the first 48 hrs. Following onset of
symptoms. Use requires the use of a special mouthpiece with the medication in powder form
added to the device. Relenza should be used with great caution in asthmatics.
SONATA (Zaleplon)
This drug is indicated for the treatment of insomnia. It differs from those currently on
the market in that it has a very short duration of action of 4 hours. For that reason it
may be of value for those who need to take medication midway through the night and who do
not want the morning "hangover" characteristic of longer acting sedatives. Side
effects are minimal however, as with other similar drugs, use with alcohol will potentiate
its depressent effects and should be avoided.
SYNERCID (Quinupristin/dalfopristin)
This injectable newly approved drug combines two semi-synthetic derviatives of a naturally
occurring drug, pristinamycin. It acts by inhibiting bacterial protein synthesis. It is
indicated for the treatment of bacterial infections, particularily those due to
Enterococcus, which are resistant to other currently available antibiotics. It can also be
used to treat skin and soft tissue infections due to streptococcus and staphylococcus
which are resistant to other antibiotics. Side effects are relatively mild with rash (1%)
and nausea (0.8%) being the most common.
TARGRETIN (Bexarotene)
This orally administered drug represents a new class of agents derived from vitamin A. It
is indicated for the treatment of cutaneous T-cell lymphoma who no longer respond to at
least one course of systemic chemotherapy. Although only 2% of patient had a complete
response, an additional 30% had a partial response. Targretin is containdicated in
pregnancy. Side effects include elevated blood lipids, itching, and edema of extremities.
TEMODAR (Temozolomide)
This newly approved drug is indicated for the treatment of refractory anaplastic
astrocytoma, a brain tumor which does not respond well to chemotherapy. Temodar produced a
22% remission rate (complete 9%) with a mean duration of responders of 64 weeks.
Significant side effects include bone marrow suppression which limited the highest dose
that could be given. Other side effects include nausea (53%), vomiting (42%), headache
(41%), fatigue (34%) and constipation (33%).
TEQUIN (Gatifloxacin) Tablets-200 and
400mg / IV-10mg/mL vials and 2mg/mL flexible containers, Rx Bristol-Myers Squibb NDA
21-061
NDA 21-062 12/17/99 Tequin (Gatifloxacin) Indications: 1. Acute Bacterial Sinusitis,
2. Community Acquired Pneumonia, 3. Acute Bacterial Exacerbation Chronic Bronchitis, 4.
Uncomplicated Urinary Tract Infections, 5. Complicated Urinary Tract Infections, 6.
Pyelonephritis, 7. Uncomplicated Gonorrhea
TIKOSYN (Dofetilide) Capsules
Pfizer Inc. NDA 20-931 10/4/99 Tikosyn Indication: (1)Maintenance of normal sinus rhythm
(delay in time to recurrence of atrial fibrillation/atrial blutter [AF/AFl]) in patients
with atrial fibrillation/atrial flutter of greater than one week duration who have been
converted to normal sinus rhythm. (2)For the conversion of atrial fibrillation and atrial
flutter to normal sinus rhythm.
TRICOR MICRO/FENOFIBRATE Capsules,
67 mg, Rx Fournier Research/Abbott NDA 019-304/S-001 2/9/98 Tricor Indication: As
an adjunctive therapy to diet for the treatment of adult patients with very high
elevations of serum triglyceride levels who are at risk of pancreatitis and who do not
respond adequately to a determined dietary effort to control them.
TROVAN/ZITHROMAX Compliance Pak, Rx Pfizer
NDA 50-762 12/18/98 7/4/99 Trovan/Zithromax Indication: sexually transmitted diseases
(STDs)
VIOXX (Rofecoxib)
Vioxx is the second of a class of antiinflammatory drugs called the COX-2 inhibitors.
Inhibition of the COX-2 enzyme reduces a cascade which leads to inflammation and the
resultant pain. It, unlike the other COX-2 inhibitor, Celebrex, is approved for pain as
well as for osteoarthritis. It, unlike, Celebrex is not approved for rheumatoid arthritis.
Side effects are generally mild and occur in <5% of patients. They include: fatigue,
lower extremity edema, increased blood pressure, heartburn, nausea, and an increased
incidence of bronchitis. This class of antiinflammatory drugs has a much lower incidence
of gastrointestinal bleeding than drugs like ibuprofen and naproxan.
VITRAVENE INJECTION (Fomivirsen sodium intravitreal
injectable) ,
6.6mg, Rx Isis Pharmaceuticals NDA 20-961 8/26/98 8/28 8/28 Vitravene Indications:
Vitravene Injection for the local treatment of cytomegalovirus (CMV) retinitis in patients
with acquired immunodeficiency syndrome (AIDS) who are intolerant of or have a
contraindication to other treatment(s) for CMV retinitis or who were insufficiently
responsive to previous treatment(s) for CMV retinitis.
ZYRTEC (Cetirizine HCl) Syrup
Pfizer NDA 20-346/S-002 5/15/98 Zyrtec Indication: These supplements provide for the use
of Zyrtec in pediatric patients 2 to 5 years of age for the indications seasonal and
perennial allergic rhinitis and chronic idiopathic urticaria
XENICAL (Orlistat)
This is the first non-controlled drug released for the treatment of obesity. It acts by
complexing fat in the intestine thus reducing fat absorption by 30-40%. Weight loss begins
in two weeks and continues for 6-12 months. The average loss is 12-15 lbs. Side effects
include: diarrhea, flatulence (gas), and oily stools.
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