FDA approves Mylan ANDA for thiamine hydrochloride injection
Mylan Institutional business has won final FDA approval for its abbreviated new drug application (ANDA) for preservative-free Thiamine Hydrochloride Injection, 100mg/ml, packaged in 200mg/2ml multiple-dose vials.
Mylan is shipping the product, which is indicated for the treatment of thiamine deficiency, presented in 25-vial packs.
According to IMS Health, Thiamine Hydrochloride Injection, 100mg/ml, had US sales of approximately $18.6m for the 12 months ending 31 March 2012.
At present, Mylan has 169 ANDAs pending FDA approval representing $83.9bn in annual sales.
Thirty-seven of the pending ANDAs are potential first-to-file opportunities, representing $25.6bn in annual brand sales, for the 12 months ending 31 December 2011, according to IMS Health.
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