Another scenario from the queen of thrush ffrom the capital of thrush I have two mom's who have exhibited classic cases of topical thrush that advanced to shooting pains intra-ductal (mammary) we've tried the Gentian V. Nystatin, miconazole /clotimazole routes with only minimal improvement topically. They are desparate. I called Pfizer/ Roerig and spoke to their Pharmacist who stated the company does not and will not recommend it 's use on lactating mothers due to the lack of information re: it's safety to the infant, as it does pass into the milk they cannot vouch for it's use. She said FDA approved its use for ages 6 months and above .Where did I READ that it was approved for neonates from day 1 I know it's used for premies , but do these kids have AIDS or are they so critical that it's worth trying anything. The co. rep. said she would mail me abstacts or lists of references of use in premies but would not fax me anything including my request for FDA approval for infants.........Does anyone.....Dr Hale? know where I heard/read re: approvel by FDA ?