The drug is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis as well as for the management of acute pain in adults.
As part of the deal, Pfizer will grant Actavis a license to market its generic Celebrex beginning in December 2014, or earlier under certain circumstances.
Launch of Actavis’ product is contingent upon the company receiving final approval from the US Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for generic Celebrex.
Based on available information, the company believes it may be a ‘first applicant’ to submit an ANDA for the generic version of Celebrex.
Actavis is focused on developing and manufacturing generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products and has commercial operations in approximately 60 countries.