Concerta: Drug for Attention Deficit Hyperactivity Disorder

For several years the drug Ritalin (methylphenidate) has benefited children with attention deficit hyperactivity disorder (ADHD), which is estimated to afflict some 3-5% of American school-age children. But the drug needs to be taken 2-3 times a day, often necessitating a trip by the child to the nurse’s office at lunchtime to take the midday dose. Now a new formulation of methylphenidate has been approved by the FDA which only requires once-daily dosing.

Sarafem: The Drug Approved for PMS

For the 3-5% of menstruating women in the US who suffer from premenstrual dysphoric disorder (PMDD, more commonly known as PMS), the FDA has officially approved the first drug that may help them: Sarafem (fluoxetine). Manufactured by Eli Lilly and Company, fluoxetine has been marketed under the trade name Prozac for the treatment of depression, obsessive compulsive disorder, and bulimia.

Ellence – Medication for Adjuvant Therapy of Breast Cancer

Ellence (pronounced el-LENCE) (epirubicin hydrochloride injection), marketed by Pharamacia &Upjohn, is an anthracycline antineoplastic antibiotic marketed as Farmorubicin(r) outside the U. S. and is currently used in more than 80 countries to treat a variety of cancers, including metastatic breast cancer.

ReFacto for Hemophilia A

To date patients with hemophilia A, the most common type, have had to rely on factor VIII products purified from human serum albumin. In March the FDA approved ReFacto (recombinant antihemophilic factor VIII), the first recombinant factor VIII product formulated without human serum albumin, for the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A.

Locilex – Antibiotic Cream for Diabetic Ulcers

Among the most common and severe complications of diabetes mellitus is the development of topical skin ulcers. These often occur at pressure points and at the extremities, and infected diabetic foot ulcers often result in limb loss.

Optivar Eyedrops for Allergic Conjunctivitis

There’s a new prescription eyedrop available for the millions of Americans who suffer from itchy eyes during hayfever season: Optivar (azelastine hydrochloride ophthalmic solution). The FDA approved the drug — which is manufactured by ASTA Medica — on May 22, 2000.

Ortho-Prefest: Another Choice for Relieving Symptoms of Menopause

A variety of types of hormone replacement therapy (HRT) are available for women who are experiencing symptoms of menopause, particularly hot flashes and vaginal atrophy. HRT has also been shown to reduce the risk of osteoporosis and heart disease. Now a new form of HRT has been approved with a once-a-day dosing schedule that will enhance patient compliance: Ortho-Prefest.

Antagon: An Aid in Artificial Fertilization

In the United States, infertility affects 6.1 percent of American women and their partners. Each year, about 2.7 million couples seek medical help for fertility problems.

Drug Vanlev for Hypertension

The most clinically advanced member of a new class of antihypertensive drugs continues to prove itself highly effective. Investigators who have conducted several different studies of the drug Vanlev (omapatrilat) presented their most recent findings at the Fifteenth Scientific Meeting of the American Society of Hypertension (ASH) in New York City. Studies have shown that Vanlev offers promise for reducing systolic blood pressure (SBP).

Zyvox (linezolid): First in a New Class of Antibiotics

Brand Name Drug: Zyvox Active Ingredient Drug: linezolid Indication: Treatment of nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections caused by indicated bacteria, in adults. Infections due to the bacteria Enterococcus faecium and methicillin-resistant Staphylococcus aureus (MRSA) pose a particular problem in hospitalized patients and in those with depressed immune systems. These organisms are often resistant to multiple antibiotics.

Corvert – Antiarrythmic Drug

Brand Name: Corvert Active Ingredient: ibutilide fumarate Indication: Corvert is used to rapidly convert atrial fibrillation or atrial flutter to sinus rhythm. Corvert (ibutilide fumarate), marketed by Pharmacia & Upjohn, is an antiarrythmic drug with predominantly class III characteristics. Class III antiarrythmic drugs prolong cardiac action potentials and increase atrial and ventricular refractoriness.

Zometa for Treatment of Tumor-induced Hypercalcemia

Tumor-induced hypercalcemia (TIH) most commonly develops in patients with advanced breast cancer, multiple myeloma, non-small cell lung cancer, and prostate cancer, and often occurs as a complication of bone metastases. TIH is potentially life-threatening, usually occurring late in malignancy and limiting survival. Signs and symptoms of tumor-induced hypercalcemia include nausea, vomiting, dehydration, renal insufficiency, mental confusion, and extremely high serum calcium levels (greater than 10.5 mg/dl).

Prevnar: A Vaccine for Pneumococcal Infections in Infants

It is estimated that each year in the US, there are about 16,000 cases of pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis among children under age 5. Children under the age of 2 are at highest risk for infection.

Targretin: Help Patients with Cutaneous T-Cell Lymphoma

Cutaneous T-cell lymphoma (CTCL) is a cancer of the T lymphocytes and afflicts between 16,000 and 20,000 people in the U. The cancer ordinarily manifests itself in the skin, but over time may progress to involve other organs. Skin lesions in CTCL patients can become deforming and culminate in ulceration, with secondary infection.

Doxil for Metastatic Ovarian Cancer

Doxil was previously approved for the treatment of AIDS-related Kaposi’s sarcoma in patients with disease that has progressed in spite of prior chemotherapy or in patients who are unable to tolerate therapy. On June 28, 1999, Doxil was granted accelerated approval for a new indication, for treatment of patients with metastatic ovarian cancer who did not respond to paclitaxel- and/or platinum-based chemotherapy. Full approval is expected once the time to progression and survival endpoint data are obtained from an ongoing Phase III, 400-patient trial.

Raptiva (Efalizumab) – drug for the treatment of plaque psoriasis

Psoriasis is an autoimmune skin disease. It is characterized by accelerated skin growth that leads to skin cells building up on the surface of the skin, forming red, raised scaly plaques. Psoriasis can involve large areas of skin and is often itchy and painful.

Remicade Plus: Drug for Rheumatoid Arthritis

Brand Name: Remicade Active Ingredient: infliximab Indication: Treatment of rheumatoid arthritis when administered with methotrexate Company Name: Centocor, Inc. Remicade (infliximab), a drug approved by the FDA in 1998 for the treatment of Crohn’s disease, was recently approved for the treatment of rheumatoid arthritis when administered with methotrexate, the standard treatment for this inflammatory disease. The drug offers hope for patients with rheumatoid arthritis in whom methotrexate does not offer adequate relief of symptoms.

Ferrlecit for Iron Deficiency

Ferrlecit is used to increase the total body content of iron in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy. Iron is crucial for normal hemoglobin synthesis and an important component of DNA metabolism and synthesis and many enzymatic processes. Erythropoietin therapy increases the production of red blood cells and iron utilization.

Pletal for the Treatment of Intermittent Claudication

Brand Name: Pletal Active Ingredient: cilostazol Approved uses: the reduction of symptoms of intermittent claudication, as indicated by an increase in walking distance Dosage Form(s): Tablets (50 mg and 100 mg) Company Name: Otsuka America Pharmaceutical, Inc. Treatment options for intermittent claudication – a severe pain, aching or cramping in the legs that occurs with walking – include exercise regimens, surgery, and pharmacological therapy. Until recently the only medication available for the treatment of intermittent claudication has been Trental(R) (pentoxifylline).

Novantrone: Managing Multiple Sclerosis

Novantrone has been used to treat prostate cancer and leukemia patients is now FDA approved for MS.It was recommended for approval by the FDA Peripheral and Central Nervous System Drugs Advisory Panel.