Table I.
Nasal Spray/Aerosol NDA Products Approved by the US FDA
| Product name | Drug name | Sponsor | Strength (mg/spray) | Approval date | Indication |
|---|---|---|---|---|---|
| Astelin Nasal Spray | Azelastine hydrochloride | Meda Pharmaceuticals | 0.125 | 11/01/1996 | Indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older. |
| Astepro Nasal Spray | Azelastine hydrochloride | Meda Pharmaceuticals | 0.1876 | 08/31/2009 | Indicated for the relief of the symptoms of seasonal and perennial allergic rhinitis in patients 12 years of age and older. |
| Atrovent Nasal Spray | Ipratropium bromide | Boehringer Ingelheim | 0.021, 0.042 | 10/20/1995 | Indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. |
| Beconase AQ Nasal Spray | Beclomethasone dipropionate | GlaxoSmithKline | 0.042 | 07/27/1987 | Indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis and for the prevention of recurrence of nasal polyps following surgical removal. |
| Dymista Nasal Spray | Azelastine hydrochloride + fluticasone propionate | Meda Pharmaceuticals | 0.137/0.05 | 05/01/2012 | Indicated for the relief of symptoms of seasonal allergic rhinitis in patients 12 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief. |
| Flonase Nasal Spray | Fluticasone propionate | GlaxoSmithKline | 0.05 | 10/19/1994 | Indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. |
| Fortical Nasal Spray | Calcitonin salmon | Upsher Smith Laboratory | 200 IU | 08/12/2005 | Indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women. |
| Imitrex Nasal Spray | Sumatriptan | GlaxoSmithKline | 5, 20 | 08/26/1997 | Indicated for the acute treatment of migraine attacks with or without aura in adults. |
| Lazanda Nasal Spray | Fentanyl citrate | Archimedes Development | 0.4 | 06/30/2011 | Indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. |
| Miacalcin Nasal Spray | Calcitonin salmon | Novartis | 200 IU | 08/17/1995 | Indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. |
| Migranal Nasal Spray | Dihydroergotamine mesylate | Valeant | 0.5 | 12/08/1997 | Indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes |
| Minirin Nasal Spray | Desmopressin acetate | Ferring Pharmaceuticals | 0.01 | 09/16/2002 | Indicated for the management of primary nocturnal enuresis. It may be used alone or adjunctive to behavioral conditioning or other nonpharmacological intervention. Also indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. |
| Nasacort AQ Nasal Spray | Trimacinolone acetonide | Sanofi Aventis | 0.055 | 05/20/1996 | Indicated for treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older. |
| Nasarel Nasal Spray | Flunisolide | Teva Branded Pharm | 0.029 | Approved on 03/08/1995; currently discontinued | Indicated for the management of the nasal symptoms of seasonal or perennial rhinitis. |
| Nasalcrom Nasal Spray | Cromolyn sodium | BlackSmith Brands | 5.2 | Approved on 1/03/1997; currently discontinued | Used to prevent and relieve nasal symptoms of hay fever and other nasal allergies including runny/itchy nose, sneezing and allergic stuffy nose. |
| Nasalide Nasal Spray | Flunisolide | Ivax Res | 0.025 | Approved on 9/24/1981; currently discontinued | Indicated for the management of the nasal symptoms of seasonal or perennial rhinitis. |
| Nascobal Nasal Spray | Cyanocobalamin | Par Pharmaceutical | 0.5 | 1/31/2005 | Indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement. Also indicated as a supplement for other vitamin B12 deficiencies. |
| Nasonex Nasal Spray | Mometasone furoate | Schering Plough | 0.05 | 10/1/1997 | Indicated for the treatment of nasal symptoms of allergic rhinitis and nasal congestion associated with seasonal allergic rhinitis. Also indicated for prophylaxis of seasonal allergic rhinitis and treatment of nasal polyps. |
| Nicotrol Nasal Spray | Nicotine | Pfizer | 0.5 | 3/22/1996 | Indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. It should be used as a part of a comprehensive behavioral smoking cessation program. |
| Omnaris Nasal Spray | Ciclesonide | Nycomed US | 0.05 | 11/21/2007 | Indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 years of age and older. |
| Patanase Nasal Spray | Olopatadine hydrochloride | Alcon Pharms | 0.665 | 4/15/2008 | Indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older. |
| Rhinocort Aqua Nasal Spray | Budesonide | AstraZeneca | 0.032, 0.064 | Approved on 10/1/1999. The 0.064 mg/spray strength currently discontinued | Indicated for the treatment of seasonal or perennial allergic rhinitis in adults and children ≥6 years. |
| Qnasl Nasal Aerosol | Beclomethasone dipropionate | Teva Branded Pharm | 0.08 | 3/23/2012 | Indicated for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. |
| Sprix Nasal Spray | Ketorolac tromethamine | Luitpold | 15.75 | 5/14/2010 Initial USA approval in 1989 | Indicated for short term (up to 5 days) management of moderate to moderately severe pain. |
| Stimate Nasal Spray | Desmopressin acetate | CSL Behring | 1.5 | 3/7/1994 | Indicated for patients with hemophilia A with Factor VIII coagulant activity levels greater than 5% and for patients with mild to moderate classic von Willebrand’s disease (type I) with factor VIII levels greater than 5%. |
| Stadol Nasal Spray | Butorphanol tartrate | BMS | 1 | Approved on 12/12/1991; currently discontinued | Indicated for the management of pain when the use of an opioid analgesic is appropriate. |
| Synarel Nasal Spray | Nafarelin acetate | GD Searle | 0.2 | 2/13/1990 | Indicated for the treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. |
| Vancenase AQ Nasal Spray | Beclomethasone dipropionate monohydrate | Schering | 0.042, 0.084 | Approved on 12/23/1987; currently discontinued. Approved on 6/26/1996; currently discontinued. | Used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. It is also used to keep nasal polyps from coming back after surgery to remove them. |
| Veramyst Nasal Spray | Fluticasone furoate | GlaxoSmithKline | 0.0275 | 4/27/2007 | Indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years. |
| Tyzine Nasal Spray | Tetrahydrozoline Hydrochloride | Pfizer | 0.1% | Approved on 10/15/1954; currently discontinued | Used to treat nasal congestion due to colds, hay fever, allergies, or sinusitis. |
| Zetonna Nasal Aerosol | Ciclesonide | Takeda Gmbh | 0.037 | 1/20/2012 | Indicated for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. |
| Zomig Nasal Spray | Zolmitriptan | AstraZeneca | 5 | 9/30/2003 | Indicated for the acute treatment of migraine with or without aura in adults. |
Data collected up to October 2012