Last week Lupin Pharmaceuticals, Inc. issued a press release announcing that it has received final FDA approval to market pregabalin, the generic version of Lyrica ® in the U.S.
Lyrica (pregabalin) was the first drug ever to be approved for the treatment of fibromyalgia . In addition to fibromyalgia, it has also been approved by the FDA for:
Treatment of neuropathic pain associated with diabetic peripheral neuropathy.
Treatment of post herpetic neuralgia.
Use an adjunctive therapy for adult patients with partial onset seizures.
Lupin's pregabalin capsules, to be available in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg doses, are the AB-rated generic equivalent of Lyrica. An AB rating means that the generic drug has been studied and has demonstrated that it is bioequivalent to the original drug.
According to the FDA, "Bioequivalence of different formulations of the same drug substance involves equivalence with respect to the rate and ...
Generic Name: PREGABALIN - ORAL Pronounced: (pree-GAH-ba-lin) Lyrica Oral Uses
This medication is used to treat pain caused by nerve
damage due to diabetes or to shingles (herpes zoster) infection. It is also
used to treat pain in people with fibromyalgia.
It is also used with other medications to treat certain
types of seizures (partial onset seizures).
How To Use Lyrica Oral
Read the Medication Guide and, if available, the Patient
Information Leaflet provided by your pharmacist before you start using
pregabalin and each time you get a refill. If you have any questions regarding
the information, consult your doctor or pharmacist.
Take this medication by mouth as directed by your doctor,
usually 2 to 3 times a day with or without food. Dosage is based on your
medical condition, kidney function, and response to treatment.
To reduce your risk of side effects (such as dizziness and
drowsiness), your doctor may direct you to star...
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...
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