Last week the U.S. Food and Drug Administration approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat fibromyalgia, chronic musculoskeletal pain, diabetic neuropathy, depression and generalized anxiety disorder.
Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. Have all received FDA approval to market duloxetine in various strengths.
“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, M.D., acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. “Generic drugs offer greater access to health care for many people.”
Are Generic Drugs Really the Same?
In the news release announcing the approval of generic versions of Cymb...
As of this writing, three medications have been approved by the FDA for the treatment of fibromyalgia: Lyrica (pregabalin), Cymbalta (duloxetine) and Savella (milnacipran). Since all three are relatively new drugs, information on how well they work and their side effects is still being gathered. Because every patient's symptoms and body chemistry are different, it is often a matter of trial and error to find the best medication for a particular patient with a particular illness. However, a recent German study , which was the first to compare the pros and cons of the three drugs head-to-head, may help doctors choose which medication has the best chance of success for any given patient. Study Design The study authors searched MEDLINE, SCOPUS, Cochrane Central Register of Controlled Trials, and sought unpublished data from the databases of FDA, US National Institutes for Health, and Industry through May 2009 for randomized controlled trials. They found 17...
Generic versions of the Migraine abortive medication Zomig (zolmitriptan) — the oral tablets and orally disintegrating tablets (Zomig-ZMT) — have been approved by the FDA and are now shipping to pharmacies.
Several manufacturers are now producing generic zolmitriptan:
Glenmark Generics is producing 2.5 and 5mg oral tablets and 2.5 and 5 orally disintegrating tablets.
Apotec, Inc. is producing 2.5 and 5mg oral tablets and 2.5 and 5 orally disintegrating tablets.
Mylan Generics is producing 2.5 and 5mg oral tablets.
Zydus Pharmaceuticals is producing 2.5 and 5mg orally disintegrating tablets.
Teva Pharmaceuticals has received tentative approval for the 2.5 and 5mg oral tablets, but is not producing or shipping yet. The patent on Zomig Nasal Spray, which was approved by the FDA later than the tablets, has not yet expired, so zolmitriptan nasal spray is not yet available.
Zomig / zolmitriptan is one of the triptan medications, a Migraine abortive medication...
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