Mylan’s Singulair Generic gets Tentative Approval

Mylan has received tentative approval from the 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 allergies. Accordin

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Mylan has received tentative approval from the 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 allergies.

According to IMS Health, Mylan has 117 ANDAs pending FDA approval, representing $82.1bn in annual brand sales.

IMS also said that 35 of these pending ANDAs are potential first-to-file opportunities, which represent $16.7bn in annual brand sales.

Mylan is a diversified generics and speciality pharmaceutical company that operates a speciality business focused on respiratory and allergy therapies.