The FDA has approved 3 allergen extracts for sublingual administration as immunotherapy for allergic rhinitis confirmed by a positive skin test or in vitro testing for pollen-specific IgE antibodies: Oralair (Stallergenes S.A./Greer) and Grastek (Merck) for grass pollen-induced allergic rhinitis and Ragwitek (Merck) for short ragweed pollen-induced allergic rhinitis.

Bepotastine besilate 1.5% ophthalmic solution (Bepreve - ISTA Pharmaceuticals), an H₁-antihistamine, has been approved by the FDA for topical treatment of itching associated with allergic conjunctivitis in patients ≥2 years old. Bepotastine was first developed in an oral systemic formulation and has been used as such for treatment of allergic rhinitis in Japan.

The FDA has approved Acuvue Theravision with Ketotifen (Johnson & Johnson Vision Care), a daily-wear, disposable, vision-correcting soft contact lens that releases the H₁-antihistamine ketotifen, for prevention of ocular itch due to allergic conjunctivitis in contact lens users. This is the first approval for a drug-eluting contact lens. Ketotifen eye drops (Alaway, Zaditor, and others) are available over the counter.

The FDA has approved a nebulized suspension of the corticosteroid budesonide for maintenance treatment of persistent asthma in children one to eight years old.

The FDA has approved marketing of the corticosteroid mometasone furoate in an orally inhaled dry powder formulation (Asmanex Twisthaler - Schering-Plough) for maintenance treatment of asthma in patients at least 12 years old. Mometasone is also available as a mid-potency topical corticosteroid cream (Elocon) and as an intranasal spray (Nasonex) for treatment of allergic rhinitis.

The FDA has approved marketing of the corticosteroid budesonide in an oral inhalatoin powder formulation (Pulmicort Turbuhaler - Astra) for maintenance treatment of asthma in adults and children at least six years old. Budesonide has been available in the USA as an intranasal spray (Rhinocort) for treatment of allergic rhinitis since 1994 and has been used for inhalation treatment of asthma in Canada and Europe for ten years.

The FDA has approved a sublingual tablet (Nocdurna – Ferring) and a nasal spray (Noctiva – Avadel) formulation of desmopressin acetate for treatment of nocturia due to nocturnal polyuria in adults who wake up ≥2 times per night to void. Nocdurna and Noctiva are the first two products to be approved in the US for this indication. Higher-strength nasal spray and oral tablet formulations of desmopressin (DDAVP, and others) have been available for years for treatment of diabetes insipidus and primary nocturnal enuresis (bedwetting in children). In 2007, the indication for primary...

Desloratadine (des lor at' a deen; Clarinex - Schering), an active metabolite of the H1-receptor antagonist loratadine (Claritin), has been approved by the FDA for oral treatment of allergic rhinitis and chronic urticaria in patients at least 12 years old. The patent for loratadine expires in December 2002, and generic or over-the-counter versions are expected.

Alcaftadine (Lastacaft – Allergan), an ophthalmic H₁-antihistamine, has been approved by the FDA for prevention of itching associated with allergic conjunctivitis in patients > 2 years old.

A 0.24% ophthalmic solution of the second-generation H₁-antihistamine cetirizine (Zerviate – Eyevance) is now available by prescription for treatment of ocular itching associated with allergic conjunctivitis in patients ≥2 years old. Oral cetirizine (Zyrtec, and others), which is used for treatment of allergic conjunctivitis and rhinitis, has been available over the counter (OTC) for years.