Firms also decided to withdraw their NDA for Claritin/Singulair combo pill, which the FDA rejected in April.
Following the FDA’s decision to decline approval of their allergic rhinitis, Schering-Plough and Merck & Co. are retracting their NDA. The companies are also ending their respiratory joint venture, resulting in a $105 million payment to Schering-Plough. The company will recognize this fee over the remaining three quarters of this fiscal year.
In May 2000, Schering-Plough and Merck formed this joint ventureto develop and market a fixed-combination product of loratadine and montelukast. In April, however, the FDA issued a not-approvable letter for this drug to be used to treat allergic rhinitis symptoms.
Loratadine is the active ingredient in Claritin, and montelukast sodium is the active ingredient in Singulair. Both medications are indicated for the relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.
