FDA Approves Once-Daily Drug for ADHD
The FDA has approved Concerta (methylphenidate) extended-release tablets by ALZA Corp. for the treatment of attention deficit hyperactivity disorder in patients 6 years and older.

Before Concerta, there was no once-daily medication for ADHD, according to a company press release. Other forms of the medication require two or three doses each day to achieve symptom improvement. Concerta uses an advanced delivery system that has been safely used in other prescription and over-the-counter medications.

Concerta is available in 18 mg and 36 mg tablets. It should be taken in the morning and must be swallowed whole. The most common side effects reported in clinical trials were headache, upper respiratory tract infection, stomachache, vomiting, loss of appetite, insomnia, cough, sore throat, sinusitis and dizziness.

Depakote ER Cleared for Migraine Prevention
The FDA has approved Depakote ER (divalproex) extended-release tablets by Abbott Laboratories for once-a-day dosing for the prevention of migraine headaches in adults. Depakote ER will be available in 500 mg tablets.

The company developed the extended-release formulation to provide migraine patients with a convenient form of Depakote.

Depakote ER demonstrated efficacy and was well-tolerated in a clinical trial with 9% of patients on placebo discontinuing the trial for adverse events compared to 8% of patients taking the drug, according to a company news release. The most common side effects associated with Depakote ER included nausea, dyspepsia, diarrhea, vomiting, abdominal pain, drowsiness and infection.

Drug Approved for Thyroid Hormone Replacement
The FDA has approved Unithroid (levothyroxine) by Jerome Stevens Pharmaceuticals for the treatment of hypothyroidism. It is the first drug indicated for thyroid hormone replacement in adults and children, according to a company news release.

Levothyroxine tablets have been marketed in the United States for more than 40 years, but the FDA's approval marks the first time that a single-ingredient, oral levothyroxine product has received formal approval through the new drug application (NDA) review process, according to a statement from the FDA.

Drug Can Prevent Menopausal Osteoporosis
The Vivelle transdermal estrogen by patch Novogyne Pharmaceuticals has been approved by the FDA for the treatment of postmenopausal osteoporosis.

The FDA first approved the 17-beta-estradiol patch in dosages of 0.0375 mg, 0.05 mg, 0.075 mg and 0.1 mg in March 1996 for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, for the treatment of vulvar and vaginal atrophy, and for the treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.

The patch delivers estradiol twice each day. Novogyne plans to release a 0.025 mg per day dose patch late this year.