Sixteen new therapeutic agents were marketed from July through December 1999, bringing the total for the year to 28, considerably lower than the more than 40 new drugs that were marketed in each of the previous 3 years.
Usually, a new drug is marketed in the same calendar year in which the FDA approved it. However, for some drugs granted FDA approval, marketing may not begin until the following year or even later. The number 28 reflects the number of new therapeutic agents actually marketed in 1999 (diagnostic agents and products such as vaccines are not included).
Brief information regarding the new agents marketed during the second half of 1999 is provided here. A comprehensive discussion of the 28 newly marketed agents will be published in the March/April issue of the Journal of the American Pharmaceutical Association.
Calfactant (Infasurf) is the third lung surfactant product to be marketed for the prevention and treatment of respiratory distress syndrome in premature infants, joining beractant (Survanta) and Exosurf Neonatal.
Doxercalciferol (Hectorol) is a synthetic vitamin D analogue that is indicated in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis.
Entacapone (Comtan) is a catechol-O-methyltransferase inhibitor that is indicated as an adjunct to levodopa/carbidopa in the treatment of Parkinson's disease. Unlike the related agent tolcapone (Tasmar), monitoring of liver function tests is not required with its use.
Epirubicin hydrochloride (Ellence) is an anthracycline antineoplastic agent that is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.
Eprosartan mesylate (Teveten) is the sixth angiotensin II receptor antagonist to be marketed for the treatment of hypertension.
Ketotifen fumarate (Zaditor) is an antihistamine and mast cell stabilizer that is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.
Oseltamivir phosphate (Tamiflu) is a neuraminidase inhibitor that is indicated for the treatment of uncomplicated acute illness due to influenza infection.
Perindopril erbumine (Aceon) is the 10th angiotension-converting enzyme (ACE) inhibitor to be marketed for the treatment of hypertension. Unlike a number of the previously marketed ACE inhibitors, it is not currently indicated for the treatment of congestive heart failure.
Pioglitazone hydrochloride (Actos) is the third thiazolidinedione to be marketed, joining rosiglitazone (Avandia) and troglitazone (Rezulin). It may be administered as monotherapy or in combination with metformin (Glucophage), a sulfonylurea, or insulin.
Quinupristin/dalfopristin (Synercid) are the first of a new class of antibacterial agents known as streptogramins. They are indicated for the treatment of serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium bacteremia and for the treatment of complicated skin and skin structure infections.
Rabeprazole (Aciphex) is the third proton pump inhibitor to be marketed, joining omeprazole (Prilosec) and lansoprazole (Prevacid).
Rapacuronium bromide (Raplon) is a nondepolarizing neuromuscular blocking agent with a rapid onset of action and short duration of action. It is indicated as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgical procedures.
Sirolimus (Rapamune) is an immunosuppressant that is indicated for the prophylaxis of organ rejection in patients receiving kidney transplants. It should be used in a regimen with cyclosporine (e.g., Neoral) and corticosteroids.
Temozolomide (Temodar) is an antineoplastic agent that is indicated for the treatment of patients with refractory anaplastic astrocytoma.
Zaleplon (Sonata) is a hypnotic that has a shorter duration of action than other agents used in the treatment of insomnia.
Zanamivir (Relenza) is a neuraminidase inhibitor that is administered by oral inhalation for the treatment of uncomplicated acute illness due to influenza infection.
Pharmacy Today. 2000;6(1) © 2000 American Pharmacists Association
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Cite this: Sixteen New Therapeutic Agents Marketed In the Second Half of 1999 - Medscape - Jan 01, 2000.