Boston, MA 06/04/2014 (wallstreetpr) – Mylan Inc. (NASDAQ:MYL) made an official announcement about its license agreement to sell the generic version of the painkiller capsules Celecoxib, also referred popularly as Celebrex, with Pfizer Inc. (NYSE:PFE).
Abbreviated New Drug Application (ANDA)
In answer to the aforementioned application made by Mylan Inc. (NASDAQ:MYL) to the US FDA, Mylan will now be able to sell and market the generic version of Celebrex in 50mg, 100mg, 200mg and 400 mg versions. There has been no light as of now on what the terms and conditions are agreed upon for this license. The decision is subject to a positive approval from the Federal Trade Commission of US and the Department of Justice.
But Mylan has clarified that they may start the sale soon and in any case it shall not be later that December this year.
How shall this help
According to a report by IMS Health, approximate sales of Celebrex capsules amounts to almost $2.34 billion. Celebrex capsules are an excellent relief for osteoarthritis. It is also said to be an assuaging painkiller for rheumatoid arthritis, severe joint pain and other such ailments. The US Food and Drug Administration made it official to the public that the generic version of Celebrex shall now be offered by Teva Pharmaceutical Industries Limited (TLV:TEVA) and Mylan Inc. (NASDAQ:MYL). Teva has received an exclusivity for 180 days to sell the 100, 200 and 400 milligram version of the capsules. Meanwhile, Mylan was allowed to sell only the 50mg tablets.
Additionally, Mylan Inc. (NASDAQ:MYL) has confirmed that it has appealed to the Federal Court’s decision to grant 180 days of exclusivity to Teva Pharmaceutical Industries Limited (TLV:TEVA). It believes the decision to be erroneous and has affirmed to continue fighting for the same. There have been no comments from TEVA on this issue.
Besides the company has also contradicted the judgement of the US district courts of West Virginia region, which denied the company’s request for a restriction in its suit towards the FDA.