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The main ingredient is valganciclovir hydrochloride, developed by the Swiss company Roche. It is an oral anti-cytomegalovirus infection drug. When were valganciclovir hydrochloride tablets launched?

In May 2001, the US FDA approved the marketing of Valcyte. It is clinically used to treat acute retinitis caused by CMV infection in patients with acquired immunodeficiency syndrome. In May 2003, its indications were expanded. Valcyte is used to prevent and treat secondary CMV infection in organ transplant recipients. On August 11, 2010, Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved valganciclovir hydrochloride tablets (Valcyte) for the treatment of adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

Roche announced on August 31, 2009 that the U.S. Food and Drug Administration (FDA) has approved Valcyte (trade name: Valcyte; generic name: valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) infection in pediatric kidney and heart transplant patients aged 4 months to 16 years. Such children are considered to be a high-risk group for CMV infection.

Precautions: Hematological disorders: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia and bone marrow failure, including aplastic anemia. May occur at any time during treatment and worsen with continued use; cell counts usually begin to recover within 3-7 days of stopping treatment. Do not use if the absolute neutrophil count is <500 cells/MM3, platelet count <25,000/m3, or hemoglobin <8 g/dl; use with caution in patients with myelosuppression, cytopenia, or patients receiving myelosuppressive drugs/radiation. Monitor CBC and platelet counts at baseline and frequently during treatment, especially in infants and patients with renal impairment, patients with prior drug-induced leukopenia, and patients with neutrophil counts <1000 cells/mm3 at the start of treatment. Pediatric: The preferred dosage form for pediatric patients is the oral solution; however, it may be used as long as the calculated dose is within 10% of the available tablet strength (450 mg). The use of valganciclovir hydrochloride tablets in the treatment of congenital cytomegalovirus disease has not been evaluated.