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Cumberland's application for arthritis, psoriasis drug accepted by US FDA

Cumberland Pharmaceuticals Inc. said the U.S. Food and Drug Administration will decide by November whether to approve its drug product line for treating arthritis and psoriasis.

The Nashville, Tenn.-based specialty pharmaceutical company said in an SEC filing that the U.S. regulator accepted for review the new drug application for its methotrexate product line to treat adults and children with arthritis and adults with psoriasis.

Arthritis is an inflammation or degeneration of one or more joints in the body, while psoriasis is a chronic skin condition caused by an overactive immune system and characterized by patches of abnormal skin.

Cumberland had submitted the application in November 2018 and paid $1.3 million to the FDA as application fee.

In 2016, Cumberland had agreed to acquire the exclusive U.S. rights to Nordic Group BV's injectable methotrexate product line used for treating active rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis and severe disabling psoriasis.