Mylan Inc., a global pharmaceutical company, has launched methocarbamol injection USP, 100 mg/mL, packaged in 1,000 mg/10 mL single-dose vials in US market. This product is the generic version of Hikma Maple Ltd.'s Robaxin.
Mylan received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Methocarbamol Injection, which is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Mylan's immediate shipment of this product supports the growth of the company's portfolio of more than 100 injectable products in the US.
Methocarbamol injection USP, 100 mg/mL, had US sales of approximately $15.1 million for the 12 months ending September 30, 2014, according to IMS Health.
Currently, Mylan has 286 ANDAs pending FDA approval representing $111.6 billion in annual brand sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $29.5 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.