Mylan Pharmaceuticals (Mylan) has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15mg and 25mg. Topiramate Capsules (Sprinkle) are the generic version of Ortho McNeil’s anticonvulsant Topamax Sprinkle Capsules, 15mg and 25mg. For the 12 months ending June 30, 2009.
Currently, Mylan has 121 ANDAs pending FDA approval representing $85.7billion in annual brand sales, according to IMS Health. 34 of these pending ANDAs are potential first-to-file opportunities, representing $17.9billion in annual brand sales, according to IMS Health.
Reportedly, Mylan is one of the quality generics and specialty pharmaceutical companies with a wide array of dosage forms and delivery systems, significant manufacturing capacity, global scale and a committed focus on quality and customer service.
Mylan also operates Matrix, manufacturer of active pharmaceutical ingredients and intermediates, making it one of only two global generic companies with a comprehensive, vertically integrated supply chain.