In recent regulatory news, Eon Labs announced the approval of a cyclosporine generic equivalent, and Bio-Rad received marketing clearance for a homocysteine assay.
* Pharmaceutical manufacturer Eon Labs of New York announced that the Food and Drug Administration granted approval for the company's AB-rated generic equivalent of Novartis Pharmaceuticals' Neoral. Patents are pending on the formulation, and the softgel capsules are expected to be available in 25-milligram and 100-milligram strengths
"Physicians and pharmacists can provide Eon cyclosporine to their patients with confidence, knowing that they will receive an AB-rated alternative in the same exact dosage form as the brand," said Frank Della Fera of Eon Labs.
The company estimated that the generic equivalent could save patients $20,000 over their lifetime. "This savings will also facilitate improved patient compliance," Eon predicted in a statement.
* Bio-Rad Laboratories, Inc., of Hercules, California, said that the FDA has given marketing clearance to the company's homocysteine by HPLC (high-performance liquid chromatography) assay. By identifying patients at risk for atherosclerotic vascular disease, the assay can help doctors "better assess the risk of coronary artery disease, senile dementia, and stroke, and more accurately monitor the health of renal, diabetic, and transplant patients," Bio-Rad said.
The HPLC assay can be run manually or partially or fully automated. Bio-Rad also makes an assay for homocysteine measurement using enzyme immunoassay technology.
For Your Information:
Eon Labs Manufacturing, Inc.
227-15 N. Conduit Ave.
Laurelton, NY 11413
(800) 526-0225
www.tylus.com/eonlabsBio-Rad Life Science Research
2000 Alfred Nobel Drive
Hercules, CA 94547
(800) 4-BIORAD
www.bio-rad.com
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