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It never has been, and it is unlikely to be, because FDA approval requires hundreds of millions of dollars in clinical trial investment that no compounding pharmacy can justify for a generic combination

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TT genotype is associated with increased risk of: Colorectal and lung cancers Unipolar depression Adult acute lymphoblastic leukemia Ischemic stroke Cleft lip/palate Down syndrome (especially when combined with methionine synthase reductase mutations) Interestingly, the 677T allele may confer reduced susceptibility to hepatitis B virus (HBV) infection in endemic regions