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 ...
So, what is a doctor to do about the abuse of pain-killers? If doctors begin to act like police officers, then the doctor-patient relationship suffers. But doctors can keep an eye out for certain risk factors which may indicate a current or future problem with narcotics in a given patient. A recent article in the "Annals of Internal Medicine" discusses such risk factors, which include mood disorders, other addictions, younger age, and male sex. Unfortunately, there are few novel treatments for pain, and therefore doctor and patient are often left only with narcotics, which have been around for a long, long time. It would be helpful to have other weapons in the fight against chronic or recurrent pain, weapons which are less addictive. In the meantime, industry and the medical profession are looking at ways to combat abuse of prescription pain-killers. For example, Oxycodone will soon be available embedded in a viscous gel. In this form, the pill cann...
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