FROM OUR EXPERTS
A case was recently reported of a 70-year-old man who developed rhabdomyolysis after his Lyrica (pregabalin) dosage was increased and he was also given Zocor (simvastatin), a statin drug usually given for high cholesterol. Rhabdomyolysis is the breakdown of muscle fibers that leads to the release of muscle fiber contents (myoglobin) into the bloodstream, which is harmful to the kidneys and often causes kidney damage.
When he arrived at the emergency room, the man was mentally disoriented, he was unable to stand up, all four extremities were twitching and he had slurred speech. Other symptoms of rhabdomyolysis may include:
Dark, red or cola colored urine
Decreased urine production
Muscle stiffness or aching
Weakness of affected muscles
Unintentional weight gain
Statin drugs are known to sometimes cause rhabdomyolysis. Lyrica is not generally recognized as a cause of rhabdomyolysis, although in t...
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 ...
Two weeks ago I told you that the FDA approved a generic version of Lyrica ® (pregabalin) made by Lupin Limited, but I wasn't able to find out when it might actually be available on the market. Now I know why I couldn't find that information. Apparently Lupin was awaiting a court decision as to whether or not on Pfizer Inc.'s patents for Lyrica were valid.
That decision came down last Thursday, July 19, 2012. Judge Gregory M. Sleet of the U.S. District Court of Delaware upheld the validity of Pfizer's patents for Lyrica, giving them exclusive rights to the medication until December 30, 2018. In addition, Judge Sleet ordered the FDA to stop approving generic forms of pregabalin until Pfizer's patents expire.
The Story Behind the Decision
In 2009, Pfizer filed a lawsuit charging patent infringement against Israel's Teva Pharmaceutical Industries, India's Sun Pharmaceutical Industries, and U.S. firms Mylan and Watson Pharmaceuticals, who all sought FDA approval ...
You should know
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