Mylan (MYL) Unit Gets FDA Approval for Thiamine Hydrochloride Injection ANDA
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Mylan Inc. (Nasdaq: MYL) announced that its Mylan Institutional business has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for preservative-free Thiamine Hydrochloride Injection, 100 mg/mL, packaged in 200 mg/2 mL multiple-dose vials. This product is indicated for the treatment of thiamine deficiency.
Thiamine Hydrochloride Injection, 100 mg/mL, had U.S. sales of approximately $18.6 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping this product, presented in 25-vial packs, immediately.
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Thiamine Hydrochloride Injection, 100 mg/mL, had U.S. sales of approximately $18.6 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping this product, presented in 25-vial packs, immediately.
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