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 ...
It has been about ten years since the United States Drug Enforcement Administration (DEA) launched what some feel is a targeted war on drugs, the battleground being your Doctor's office. The DEA feels there has continued to be a diversion of prescription narcotics for use on "the street." I am not sure this is what they had in mind for Main Street.
The focus on physicians is perhaps the least resistant path to the easier drug bust; after all, physicians are supposed to maintain records of prescriptions written, and document the reasoning behind and the plans for the continued use of a prescription drug. That drug dealer out on the street is a tougher collar.
Physicians have been put through the wringer of the American judicial system, on charges ranging from drug dealing to murder, charges rooted in the over-prescribing of narcotic medications. There is a certain irony here, as such woes have befallen physicians in parallel with the development of drugs that have all...
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