Grunenthal tablets approved by FDA

Pharmaceutical Company Product News

Grunenthal has said its Tapentadol immediate release tablets have been approved by the US Food and Drug Administration.

The drug is an oral centrally-acting analgesic and is used for the relief of moderate to severe acute pain for adults aged 18 years and over.

In the European Union, Tapentadol is currently in phase III development, with the company planning submission in Europe for the second quarter of 2009.

Professor Paques, member of the executive board of Grunenthal, said the product "represents a great success".

He continued: "Tapentadol is a major milestone in Grunenthal's ambition to be one of the world leaders in providing patients suffering from pain."

"[It] is one of several exciting compounds we have in our pipeline."

Grunenthal and Johnson & Johnson Pharmaceutical Research & Development have shared development responsibilities for Tapentadol since the two companies signed a licensing agreement in 2003.

Additionally, the organisation licensed rights to the therapy to Ortho-McNeil-Janssen Pharmaceutical - for marketing in Japan, the US and Canada.

It however maintains the privileges in Europe and other parts of the world.

Formed in 1946, Grunenthal is a family-owned research-based pharmaceutical company.

The organisation has products marketed in over 80 countries and currently employs 4,800 people around the world.

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