Mylan introduces Tramadol HCl extended-release tablets in US market

Mylan N.V.,a global pharmaceutical company, announced the US launch of Tramadol hydrochloride extended-release tablets USP, 100 mg, 200 mg and 300 mg, which is the generic version of Valeant's Ultram extended-release tablets.

Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Tramadol hydrochloride extended-release tablets USP, 100 mg, 200 mg and 300 mg, had US sales of approximately $52.8 million for the 12 months ending December 31, 2015, according to IMS Health.

Currently, Mylan has 265 ANDAs pending FDA approval representing $110.3 billion in annual brand sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $38.3 billion in annual brand sales, for the 12 months ending Dec. 31, 2015, according to IMS Health.

[tags Mylan,pharmaceutical,,regulatory,ANDAs, ]