Tentative FDA OK for Mylan's generic Singulair
US generics major Mylan has received tentative approval from the Food and Drug Administration for its Abbreviated New Drug Application for montelukast sodium tablets, 10mg (base).
The drug is the generic version of Merck & Co's Singulair, which had total US sales of around $2.6 billion for the 12 months ending March 31 for the same strength, according to IMS Health. This product is indicated for asthma and allergy treatment.
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