FDA Approves Generic CMV Disease Drug

Aurobindo Pharma Limited has received final approval from the FDA to launch valganciclovir tablets USP, 450 mg, which are therapeutically equivalent to Hoofman-LaRoche’s Valcyte.

The antiviral is designed to treat cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome. It may also be used to prevent CMV disease in patients with kidney, heart, or kidney-pancreas transplants who are at high risk.

For the fiscal year ending in February 2016, the treatment had a market worth of $390.6 million, according to IMS.

Some adverse effects associated with Valcyte include diarrhea, nausea, vomiting, tremors, low blood cell counts, rejection of the transplanted organ, and fever.

Patients on Valcyte may also have a heightened chance of developing cancer or giving birth to children with defects. Valcyte may also lower sperm count and affect fertility in both men and women.