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news.Mylan has declared that it has received tentative approval from FDA for its Abbreviated New Drug Application (ANDA) for Montelukast Sodium Tablets. Montelukast Sodium Tablets are the generic version of Merck and Co.'s Singulair, which is used for the treatment of asthma and allergy.
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According to IMS Health, Mylan has currently 117 ANDAs pending FDA approval, representing $82.1 billion in annual brand sales.
Moreover, IMS also said that 35 of these pending ANDAs are potential first-to-file opportunities, which represent $16.7 billion in annual brand sales.
Mylan is a diversified generics and specialty pharmaceutical company that operates a specialty business focused on respiratory and allergy therapies.