Indoco Remedies gains USFDA approval for Pregabalin capsules

Indoco Remedies announced the receipt of final approval from the  United States Food and Drug Administration (USFDA for Abbreviated New Drug Application (ANDA) for Pregabalin capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg. This is a generic equivalent of the Reference Listed Drug, Lyrica Capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300 mg, of Upjohn US  LLC.

This product, Pregabalin capsules, will be manufactured by Indoco Remedies, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India. Pregabalin is used for Neuropathic pain associated with diabetic peripheral neuropathy and spinal cord injury, Postherpetic neuralgia, and Fibromyalgia.

 

Abbreviated New Drug Applicationdiabetic peripheral neuropathyFibromyalgiaIndoco RemediesLyrica capsulesPostherpetic NeuralgiaPregabalin CapsulesUnited States Food and Drug Administration
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