NEW DRUGS
The new beta blocker Bystolic (nebivolol) from Forest Laboratories, (800) 678-1605, has been approved by the FDA for the treatment of hypertension alone
or in combination with other antihypertensive agents. The medication has already been approved in 50 other countries. Bystolic
will be available in 2.5-, 5-, and 10-mg tablets. Patients treated with Bystolic should not discontinue therapy abruptly because
of the risk of exacerbating angina and the occurrence of myocardial infarction and ventricular arrhythmias.
NEW INDICATIONS
Diovan (valsartan) Tablets from Novartis, (862) 778-8300, has received FDA approval for a new indication. The angiotensin receptor blocker has been
approved for the treatment of high blood pressure in children and adolescents ages six to 16. Diovan is still not indicated
for children under the age of six. The FDA has granted Hill Dermaceuticals, (888) 445-5468, a new indication for Derma-Smoothe/FS Topical Oil. The low-potency corticosteroid treatment system is now approved for use in children as young as three months old. Previously
the medication was approved only for adults and children above the age of two.
Genzyme's Thyrogen (thyrotropin alfa for injection), (617) 252-7500, can now be used in combination with radioiodine to ablate or destroy the
remaining thyroid tissue in patients who have had cancerous thyroids removed. Thyrogen was originally approved in 1998 for
use as a diagnostic tool for patients being tested for the recurrence of thyroid cancer.
NEW DELIVERY SYSTEM
EMD Serono, (919) 401-7100, announced that easypod, an automated device for administering Saizen (somotropin for injection), is now available. In October 2007 the FDA approved easypod, which received the 2007 Gold Medal
from the Medical Design Excellence Awards. Saizen is indicated for the treatment of children and adults with growth hormone
deficiency.
NEW GENERICS
Amneal Pharmaceuticals, (973) 357-0222, has received FDA approval for bethanechol chloride tablets, USP in 5-, 10-, 25-, and 50-mg strengths under the new expedited approval process. As a generic equivalent to Barr Laboratories'
Urecholine, bethanechol chloride is indicated for acute postoperative and postpartum non-obstructive urinary retention and
for neurogenic atony of the urinary bladder with retention.
The FDA has approved the application by Caraco Pharmaceutical Laboratories, (318) 871-8400, to manufacture amlodipine besylate in 2.5-, 5-, and 10-mg tablets. Amlodipine is the bioequivalent of Pfizer's Norvasc. Amlodipine is indicated for the treatment
of hypertension, the symptomatic treatment of chronic stable angina, and the treatment of confirmed or suspected vasospastic
angina.
Teva Pharmaceuticals, (888) 738-2872, has been granted approval to manufacture oxcarbazepine tablets in 150-, 300-, and 600-mg sizes. The medication is the generic equivalent of Trileptal from Novartis and is indicated for
use alone or in combination with other medications for the treatment of partial seizures in adults and children four years
of age and older.
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