Granules India announced that the US Food & Drug Administration has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc., a wholly owned foreign subsidiary of Granules India for Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL. It is
bioequivalent to the reference listed drug product (RLD), Valcyte for Oral Solution, 50 mg/mL, of Roche Palo Alto LLC.
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