Mylan has received approval from the FDA for its Abbreviated New Drug Application (ANDA), for Liothyronine Sodium Tablets USP, 5 mcg (base), 25 mcg (base) and 50 mcg (base).
Liothyronine Sodium Tablets are the generic version of King’s thyroid deficiency treatment – Cytomel.
Currently, Mylan has 120 ANDAs pending FDA approval representing $84.7 billion in annual brand sales, according to IMS Health. 35 of these pending ANDAs are potential first to file opportunities, representing $16.6 billion in annual brand sales, said IMS Health.
Mylan’s fully integrated specialty business provides the company with diversified opportunities in the respiratory and allergy therapeutic areas, across the globe.