Fluoxetine, a selective serotonin reuptake inhibitor (SSRI) previously sold only as Prozac, is now also marketed as Sarafem for treatment of premenstrual dysphoric disorder (PMDD). Generic fluoxetine is expected to be available sometime this year.

The FDA had approved an intrauterine contraceptive device that releases the synthetic progestin levonorgestrel over a period of five years. The device has been available in Europe for 10 years.

Tinzaparin sodium, a low molecular weight heparin, has been approved by the FDA for treatment of acute deep vein thrombosis.

Galantamine hydrobromide (Reminyl), a tertiary alkaloid and phenanthrene derivative extracted from daffodil bulbs, is now being marketed for oral treatment of mild to moderate Alzheimer's disease. Galantamine is the fourth acetylcholinesterase inhibitor approved for this indication.

CroFab, an antigen-binding-fragment (Fab) antivenom of ovine origin, has been approved by the FDA for treatment of North American rattlesnake envenomation.

Recent reports of inappropriate use and diversion of OxyContin tablets have prompted Purdue Pharma to include a "Black Box Warning"in the product labeling to call attention to the potential for abuse and to reinforce the FDA-approved indication "...for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time..."

Zoledronic acid (Zometa), a new bisphosphonate, has been approved by the FDA for intravenous (IV) treatment of hypercalcemia of malignancy.

Since the last Medical Letter article on glucosamine for osteoarthritis (vol.39, page 91, September 26, 1997), more data have become available. Glucosamine is available in US pharmacies and health food stores as sulfate, hydrochloride or n-acetyl salt.

Recombinant human granulocyte colony stimulating factor (G-CSF, filgrastim) conjugated to polyethylene glycol (pegfilgrastim, Neulasta - Amgen) has been approved by the FDA for use in neutropenic patients with non-myeloid malignancies who are at high risk for infection. Filgrastim (Neupogen - Amgen) has been available in the US since 1991.

Dexmethylphenidate (Focalin - Novartis), a new formulation of methylphenidate (Ritalin, and others) is now available for treatment of attention deficit/hyperactivity disorder (ADHD). Dexmethylphenidate is the d-threo-enantiomer of racemic methylphenidate. "Now the right half may be all your patients need," said a recent ad. Focalin is the third new methylphenidate formulation marketed in the last two years.