Zeneca, Inc. has received FDA clearance for an alternative method of administration of the pellets contained in Kadian (morphine sulfate sustained release) capsules. As an alternative to swallowing Kadian capsules whole, now Kadian capsules may be opened and the entire contents sprinkled on a small amount of applesauce (other foods were not tested). The pellets inside the capsules should not be chewed, crushed, or dissolved due to risk of overdose. Kadian is the first and only oral sustained-release morphine in the U.S. to offer 24-hour pain control with the option of a single daily dose, and now with the ability to be "sprinkle" administered.
Roche has received approval to market Tasmar (tolcapone) for the adjunctive treatment of Parkinson's disease with levodopa. Tolcapone inhibits the enzyme responsible for the metabolism of levodopa to a breakdown product, 3-O-methyldopa. The drug increases the amount of levodopa reaching the brain while improving its delivery.
Bedford Laboratories, Inc., a major marketer for injectable pharmaceuticals, has received tentative FDA approval to market the first generic version of ranitidine hydrochloride injection. Mylan Pharmaceuticals, Inc. also has received approval to market ranitidine in tablet form. The products are generic alternatives to Glaxo Wellcome's Zantac, an H2 antagonist.
Organon, Inc., has received FDA clearance to market Follistim (follitropin beta for injection), the first recombinant follicle-stimulating hormone available in the U.S. for the treatment of infertility. Follistim will be marketed for the development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology program. It is also being marketed for the induction of ovulation and pregnancy in the anovulatory infertile patient with functional infertility not due to primary ovarian failure.
Abbott Laboratories has received regulatory clearance from the FDA to market Gabitril (tiagabine hydrochloride). Gabitril treats partial seizures. The precise mechanism of action of Gabitril is unknown, although it is believed to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system.
Wyeth-Ayerst's Duract (bromfenac), an NSAID, has been approved by the FDA for the short-term (less than 10 days) management of pain.
Bristol-Myers Squibb's Taxol (paclitaxel) has received approval for an orphan indication as second-line treatment for AIDS-related Kaposi's sarcoma.
Zeneca's new antipsychotic Seroquel (quetiapine) has been approved by the FDA. The drug will be manufactured in the U.S. and will be available in 25mg, 100mg, and 200mg tablet formulations.
Pfizer's Zoloft (sertraline) has been approved for the treatment of panic disorder. Zoloft is widely used for treatment of depression and obsessive-compulsive disorder.
Amgen announced that the FDA has granted marketing clearance for Infergen (Interferon alfacon-1), a bioengineered drug, for the treatment of chronic hepatitis C viral (HCV) infection. The drug has been shown to be safe and effective in HCV patients who have never been treated with previous interferon therapy. In addition, HCV patients who have not responded or who have relapsed after prior treatment with Interferon alfa-2b or Infergen may also benefit from subsequent treatment with Infergen.
Boehringer Ingelheim Pharmaceuticals, Inc. announced the U.S. availability of once-daily Flomax (tamsulosin HCl) capsules, the first alpha blocker developed specifically for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Not indicated for hypertension, Flomax provides improvement in urine flow and BPH symptoms common in older men. In addition, Flomax can be added to common antihypertensive and cardiovascular regimens without dosage adjustments.
