Granules India arm gets USFDA nod for Valganciclovir hydrochloride oral solution

Valganciclovir hydrochloride solution is an antiviral medication used to treat cytomegalovirus infections

Granules India said its foreign arm has received approval from the US health regulator for Valganciclovir hydrochloride oral solution, an antiviral medication.

“The US Food & Drug Administration (US FDA) 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,” the company said in a regulatory filing.

It is bioequivalent to the reference listed drug product (RLD) — Valcyte for oral solution, 50 mg/m, of Roche Palo Alto LLC, the filing said. Valganciclovir hydrochloride solution is an antiviral medication used to treat cytomegalovirus infections.