Treatment of primary brain malignancies (grade III and IV astrocytomas).

Warner-Lambert Company

2800 Plymouth Rd., P.O. Box 1047

Alpha-1-antitrypsin (recombinant DNA Origin)

As supplementation therapy for alpha-1-antitrypsin deficiency in the ZZ phenotype population.

Treatment of advanced adenocarcinoma of the ovary.

Single agent palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent based combination.

Medimmune Oncology, Inc.

100 Front St., Suite 400

West Conshohocken

Pennsylvania

Pentamidine isethionate

Treatment of Pneumocystis carinii pneumonia.

Levocarnitine

Treatment of genetic carnitine deficiency.

Leadiant Biosciences, Inc.

Gaithersburg

Cromolyn sodium

755 Jefferson Rd., P.O. Box 1710

Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.

A. L. Laboratories, Inc.

P.O. Box 1399

Amelioration of recurrent attacks of acute intermittent porphyria (AIP) temporarily related to the menstrual cycle in susceptible women and similar symptoms which occur in other patients with AIP, porphyria variegata and hereditary coproporphyria.

Ethanolamine oleate

Treatment of patients with esophageal varices that have recently bled, to prevent rebleeding.

Botulinum toxin type A

Treatment of strabismus and blepharospasms

Treatment of strabismus associated with dystonia in adults (patients 12 years of age and above)

P.O. Box 19534

Botulinum toxin type A

Treatment of strabismus and blepharospasms

Treatment of blepharospasm associated with dystonia in adults (patients 12 years of age and above)

P.O. Box 19534

Epoprostenol

Replacement of heparin in patients requiring hemodialysis and who are at risk of hemmorrage

Research Triangle Park

North Carolina

Chemet Capsules

Bock Pharmacal Company

Pegademase bovine

For enzyme replacement therapy for ADA deficiency in patients with severe combined immunodeficiency.

Sigma-tau Pharmaceuticals, Inc.

Gaithersburg

Monooctanoin

For dissolution of cholesterol gallstones retained in the common bile duct.

Ethitek Pharmaceuticals, Inc.

Treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum.

Novartis Pharmaceutical Corporation

East Hanover

viloxazine HCL

Stuart Pharmaceuticals

Levocarnitine

Treatment of primary and secondary carnitine deficiency of genetic origin.

Treatment of primary systemic carnitine deficiency. (approved 12/27/85) Treatment of secondary carnitine deficiency. (approved 12/16/92)

Leadiant Biosciences, Inc.

Gaithersburg

Iodine 131 6B-iodomethyl-19-norcholesterol

University of Michigan Medical Center/1500 E. Med.

B1G412 /0028 University Hospital

For patients with radiolucent stones in well opacifying gallbladders, in whom elective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age

Quinacrine hydrochloride

For prevention of recurrence of pneumothorax in patients at high risk of recurrence.

For symptomatic relief and parasitic cure of chronic cryptosporidiosis in patients with immunodeficiency.

Rhone-Poulenc Rorer Pharmaceuticals

Pennsylvania

Cyproterone acetate

Berlex Laboratories, Inc.

Epoprostenol

Replacement of heparin in patients requiring hemodialysis and who are at increased risk of hemorrhage.

Pentamidine isethionate

Treatment of Pneumocystis carinii pneumonia.

PO Box 61501

King of Prussia

Pennsylvania

Potassium citrate

1. Prevention of calcium renal stones in patients with hypocitraturia 2. For avoidance of the complication of calcium stone formation in patients with uric lithiasis.

Prevention of recurring calcium conating stines associated with a deficiency in the urine.

University of Texas Health Science Center at Dallas

Potassium citrate

University of Texas Health Science Center at Dallas

Digoxin immune FAB (Ovine)

Treatment of potentially life threatening digitalis intoxication in patients who are refractory to management by conventional therapy.

Research Triangle Park

North Carolina

Vumon For Injection

Treatment of refractory childhood acute lymphocytic leukemia.

Induction therapy in patients with refractory childhood acute lymphoblastic leukemia when used in combination with other approved anticancer agents.

Bristol-Myers Squibb Pharmaceutical Research Institute

P.O. Box 5100

L-5 Hydroxytrytophan

Treatment of postanoxic intention myoclonus.

Watson Laboratories, Inc.

For acceleration of corneal epithelial regeneration and healing of stromal incisions from corneal transplant surgery.

Selegiline HCl

As an adjuvant to levodopa and carbidopa treatment of idiopathic Parkinson's disease (paralysis agitans), postencephalitic Parkinsonism, and symptomatic Parkinsonism.

Somerset Pharmaceuticals, Inc.

Antimelanoma Antibody XMMME-001-DTPA 111 Indium

Antimelanoma Antibody Xmmme-001-Dtpa 111 Indium

Diagnostic use in imaging systemic and nodal melanoma metastasis.

Antimelanoma Antibody XMMME-001-RTA

Antimelanoma Antibody Xmmme-001-Rta

Treatment of stage III melanoma not amenable to surgical resection.

Iobenguane Sulfate I 131

For use as a diagnostic adjunct in patients with pheochromocytoma.

Designated/Approved/Withdrawn

Adjunctive diagnostic agent in the localization of primary or metastatic pheochromocytomas.

University of Michigan

1500 E. Medical Center Drive

Antithrombin III (human)

Thrombate Iii

For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli.

Pharmaceutical Division, Biological Products

400 Morgan Lane

Alpha1-proteinase inhibitor (human)

For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state.

For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emphysema.

Pharmaceutical Division, Biological Products

400 Morgan Lane

Warner-Lambert Company

Sodium monomercaptoundecahydro-closo-dodecaborate

For use in conjunction with a thermal or epithermal neutron beam in boron nuclear capture therapy of glioblastoma multiforme.

Theragenics Corporation

Trientine HCl

Treatment of patients with Wilson's disease who are intolerant, or inadequately responsive to penicillamine.

Merck Sharp & Dohme Research

Division Of Merck And Company

Pennsylvania

Protirelin injection

Treatment of amyotrophic lateral sclerosis.

Treatment of hyperbilirubinemia in newborn infants unresponsive to phototherapy.

1720 Post Road East

factor XIII concentrate (human)

Treatment of congenital factor XIII deficiency

For the routine prophylactic treatment of congenital factor XIII deficiency

PO Box 61501

King of Prussia

Pennsylvania

factor XIII concentrate (human)

Treatment of congenital factor XIII deficiency

Peri-operative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency.

PO Box 61501

King of Prussia

Pennsylvania

physostigmine salicylatephysostigmine salicylate

Treatment of Friedreich's and other inherited ataxias.

Forest Pharmaceuticals.3-.3-.30 6

Gamma-hydroxybutyric acid

Treatment of narcolepsy and the auxiliary symptoms of cataplexy, sleep paralysis, hypnagogic hallucinations, and automatic behavior.

Sigma Chemical Company

Levomethadyl acetate hydrochloride

Treatment of heroin addicts suitable for maintenance on opiate agonists.

For the management of opiate dependence.

Biodevelopment Corporation

8180 Greensboro Drive, Suite 1000

Erwinia L-asparaginase

For use as an alternative to E. coli asparaginase in those situations where repeat courses of asparaginase therapy for acute lymphoblastic leukemia are required or where allergic reactions force the discontinuance of the E. coli preparation.

Antithrombin III (human)

For the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.

Pharmacia & Upjohn AB

Antipyrine Test

For use as an index of hepatic drug-metabolizing capacity.

Upsher-Smith Laboratories, Inc

Epidermal growth factor (human)

For promotion of cutaneous wound healing in extreme burn treatment protocols.

Superoxide dismutase (human)

For protection of donor organ tissue from damage or injury mediated by oxygen-derived free radicals that are generated during the necessary periods of ischemia (hypoxia, anoxia), and especially reperfusion, associated with the operative procedure.

Pharmacia-Chiron Partnership

Naltrexone HCl

For blockade of the pharmacological effects of exogenously administered opioids as an adjunct to the maintenance of the opioid-free state in detoxified formerly opioid-dependent individuals.

DuPont Pharmaceuticals

Alglucerase injection

For replacement therapy in patients with Gaucher's disease type I.

Long-term enzyme replacement therapy for children, adolescents and adult patients with a confirmed diagnosis of Type I Gaucher disease who exhibit signs and symptoms that are severe enough to result in one or more of the following conditions: a) moderate-to-severe anemia; b) thrombocytopenia with bleeding tendency; c) bone disease; d) significant hepatomegaly or splenomegaly.

Genzyme Corporation

Massachusetts

Digoxin immune fab(ovine)

Treatment of life-threatening acute cardiac glycoside intoxication manifested by conduction disorders, ectopic ventricular activity and (in some cases) hyperkalemia.

Boehringer Mannheim Corp.

Oxymorphone

Numorphan H.P.

For relief of severe intractable pain in narcotic-tolerant patients.

DuPont Merck Pharmaceutical Company

Treatment of squamous metaplasia of the ocular surface epithelia (conjunctiva and/or cornea) with mucous deficiency and keratinization.

Hannan Ophthalmic Marketing Services, Inc

Massachusetts

Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.

Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.

Treatment of severe human cytomegalovirus infections in specific immunosuppressed patient populations.

Burroughs Wellcome Company

P.O. Box 12700

Research Triangle Park

North Carolina

Roberts Pharmaceutical Corp.

Four Industrial Way West

Prednimustine

Treatment of malignant non-Hodgkin's lymphomas.

Midodrine HCl

Treatment of patients with symptomatic orthostatic hypotension.

Treatment of symptomatic orthostatic hypotension.

Pennsylvania

Antithrombin III (human) concentrate IV

For prophylaxis and treatment of thromboembolic episodes in patients with genetic AT-III deficiency.

PO Box 61501

King of Prussia

Pennsylvania

Treatment of thrombotic thrombocytopenic purpura.

Villa Guardia, Italy

Management of certain adult patients with symptomatic HIV infection (AIDS and advanced ARC) who have a history of cytologically confirmed Pneumocytis carinii pneumonia (PCP) or an absolute CD4 (T4 helper/induccer) lymphocyte count of less than 200/mm in the peripheral blood before therapy is begun

Research Triangle Park

North Carolina

ammonium 21-tungsto-9-antimoniate

Treatment of acquired immunodeficiency syndrome.

Rhone-Poulenc Rorer Pharm.

Pennsylvania

Cromolyn sodium 4% ophthalmic solution

Opticrom 4% Ophthalmic Solution

P.O. Box 1710

Trimetrexate glucuronate

Treatment of pancreatic adenocarcinoma.

Medimmune Oncology, Inc.

Gaithersburg

Pentosan polysulfate sodium

Relief of bladder pain or discomfort associated with interstitial cystitis.

PO Box 10950

Treatment of soft tissue and bone sarcomas

Bristol-Myers Squibb Company

Mail Stop D12-02

As an adjunct in leukapheresis to improve the harvesting and increase the yield of leukocytes by centrifugal means.

DuPont Pharmaceuticals

tranexamic acid

Treatment of hereditary angioneurotic edema

Designated/Approved/Withdrawn

Treatment of patients with hemophilia for short term use (2 to 8 days) before and after tooth extraction to reduce or prevent hemorrhage abd reduce the need for replacement therapy

Rifampin, isoniazid, pyrazinamide

For the short-course treatment of tuberculosis.

Short-course treatment of tuberculosis.

Hoechst Marion Roussel

Epoprostenol

Treatment of primary pulmonary hypertension.

Long-term intravenous treatment of primary pulmonary hypertension in NYHA Class III and Class IV patients.

Research Triangle Park

North Carolina

Hydroxycobalamin/sodium thiosulfate

Treatment of severe acute cyanide poisoning.

Methotrexate sodium

Methotrexate

For the use of high dose methotrexate with leucovorin rescue in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor.

Division of American Cyanamid Company

401 N. Middletown Road

Ganciclovir sodium

Treatment of cytomegalovirus retinitis in immunocompromised patients with AIDS.

Designated/Approved/Withdrawn

Monoclonal antiendotoxin antibody XMMEn-0e5

Treatment of patients with gram-negative sepsis which has progressed to shock.

For maintenance treatment of patients with Wilson's disease who have been initially treated with a chelating agent.

Pennsylvania

For use as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.

Ridgefield Park

Allopurinol riboside

1. Treatment of Chagas' disease 2. Treatment of cutaneous and visceral leishmaniasis

Burroughs Wellcome Company

P.O. Box 12700

Research Triangle Park

North Carolina

Somatrem for injection

1. Long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion (prevalence 15,000) 2. Treatment of short stature associated with Turner's syndrome (prevalence 8000).

South San Francisco

For antituberculosis treatment where use of the oral form of the drug is not feasible.

Hoechst Marion Roussel

For arresting the progression of neurologic disability caused by chronic progressive multiple sclerosis.

Pharmacontrol Corporation

661 Palisade Ave., P.O. Box 931

Englewood Cliffs

Antithrombin III human

Antithrombin Iii Human

Preventing or arresting episodes of thrombosis in patients with congenital AT-III deficiency and/or to prevent the occurrence of thrombosis in patients with AT-III deficiency who have undergone trauma or who are about to undergo surgery or parturition.

American National Red Cross

Janssen Research Foundation

Guanethidine monosulfate

Treatment of moderate to severe reflex sympathetic dystrophy and causalgia.

Novartis Pharmaceuticals Corporation

East Hanover

Prevention of cystine nephrolithiasis in patients with homozygous cystinuria.

Pak, Charles Y.C. M.D.

The University of Texas Health Scienc Center at Da

5323 Harry Hines Boulevard

Benzoate and phenylacetate

For adjunctive therapy in the prevention and treatment of hyperammonemia in patients with urea cycle enzymopathy due to carbamylphosphate synthetase, ornithine, transcarbamylase, or argininosuccinate synthetase deficiency.

P.O. Box 19791

Anti pan T lymphocyte monoclonal antibody

Anti-T Lymphocyte Immunotoxin Xmmly-H65-Rta

1. For ex-vivo treatment to eliminate mature T cells from potential bone marrow grafts 2. For in-vivo treatment of bone marrow recipients to prevent graft rejection and graft versus host disease.

Survanta Intratracheal Suspension

Treatment of neonatal respiratory distress syndrome

Treatment of ("rescue") of premature infants with RDS confirmed by x-ray and requiring mechanical ventilation

Survanta Intratracheal Suspension

Treatment of neonatal respiratory distress syndrome

Prevention of RDS (hyaline membrane disease) in premature infants less than 1250 grams birthweight or with evidence of surfactant deficiency

Potassium citrate and citric acid

For the dissolution and control of uric acid and cysteine calculi in the urinary tract.

Treatment of bleeding esophageal varices.

Ferring Pharmaceuticals Inc.

Parsippany-Troy Hills

Etidronate disodium

Treatment of hypercalcemia of malignancy inadequately managed by dietary modification and/or oral hydration.

Diethyldithiocarbamate

Connaught Laboratories

Pennsylvania

Treatment of anemia associated with end stage renal disease.

Treatment of anemia associated with chronic renal failure, including patients on dialysis (end stage renal disesae) and patients not on dialysis

Thousand Oaks

Eflornithine HCl

Treatment of Pneumocystis carinii pneumonia in AIDS patients.

Marion Merrell Dow, Inc.

Eflornithine HCl

Treatment of Trypanosoma brucei gambiense infection (sleeping sickness).

Hoechst Marion Roussel