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FDA approves generic Lyrica


Lupin has received FDA approval to market a generic version of Lyrica (Pfizer), but the company has not yet launched it, according to Firstword Pharma.

The Sacramento Bee reported that Lupin received approval for 25-mg, 50-mg, 75-mg, 100-mg, 150-mg, 200-mg, 225-mg, and 300-mg pregabalin capsules, which are the AB-rated generic equivalent of Lyrica capsules.

Patents on Lyrica expire in the United States between October 2013 and the end of 2018.

Lyrica is indicated for neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures, fibromyalgia, and neuropathic pain associated with spinal cord injury.

Lyrica tallied U.S. sales of about $1.8 billion for the year ended in March, according to data from IMS Health Inc.

“Pregabalin has become a very popular drug for treating certain types of seizure disorders, post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, and neuropathic pain,” said James M. Wooten, PharmD, associate professor, department of medicine, University of Missouri-Kansas City School of Medicine, and advisor for Formulary, the sister publication of Drug Topics. “Because these symptoms affect a wide array of patients, the use of the drug has steadily increased. The drug is also marketed directly to the consumer so many patients are familiar with the drug before discussing its use with their physicians. Generic pregabalin would be a welcome addition as long as its cost is less than the brand name Lyrica. Unfortunately, predicting the cost of future generic drugs is not always accurate, so it is prudent to wait and assess the economic impact of generic pregabalin until more cost data is available.”

FDA recently released the results of an analysis of a limited number of samples of hydroxyprogesterone caproate active pharmaceutical ingredients and compounded hydroxyprogesterone caproate, finding no major safety concerns.


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