JB Chemicals gets US FDA nod for generic Tegretol XR tablet
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Mumbai: JB Chemicals & Pharmaceuticals Limited has announced that the US FDA has approved Company's Abbreviated New Drug Application (ANDA) for Carbamazepine Extended-Release Tablets USP 100 mg, 200 mg and 400 mg for the treatment of Epilepsy and Trigeminal Neuralgia.
The product is a generic version of Tegretol XR tablet in the same strength of Novartis Pharmaceuticals Corp.
According to IQVIA, US sales were approximately USD 128 million.
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