Generic Lyrica Gets FDA Approval

Patient Expert

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 extent of drug absorption. Two formulations whose rate and extent of absorption differ by -20 percent/+25 percent or less are generally considered bioequivalent. The use of the -20 percent/+25 percent rule is based on a medical decision that, for most drugs, a -20 percent/+25 percent difference in the concentration of the active ingredient in blood will not be clinically significant."

There was no mention in the press release of exactly when we can expect this product to be available in U.S pharmacies. I am trying to get in touch with someone at Lupin and will let you know if and when I get any further information.

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