Barr Laboratories received final FDA approval for its fexofenadine HC1 capsules in 60 mg strength, the generic version of Aventis Pharmaceuticals' Allegra, indicated for the relief of symptoms associated with seasonal allergic rhinitis and for treating uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children. Barr is entitled to 180 days of marketing exclusivity on the product.
In other news, Barr received final FDA approval for its generic version of DDAVP (desmopressin acetate) tablets in 0.1 mg and 0.2 mg dosages. Barr is the first to file an ANDA and is entitled to 180 days of marketing exclusivity. DDAVP tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. They also are indicated for the management of primary nocturnal enuresis. DDAVP had annual branded sales of $191 million per IMS Health data for the 12 months ended in April.
Barr also confirmed that Janssen Pharmaceutica Products and Synaptech filed suit against the company relating to the patents protecting Razadyne (galantamine hydrobromide), formerly called Reminyl, in 4 mg, 8 mg and 12 mg tablets. The drug is indicated for treating mild to moderate dementia of the Alzheimer's type. The suit officially initiates the patent challenge process under the Hatch-Waxman Act. Razadyne had annual branded sales of $247 million for the 12 months ended in April, according to IMS Health data.
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