FDA Approves New Drug Application for Carbinoxamine

FDA Approves New Drug Application for Carbinoxamine

FDA Approved April 2013 carbinoxamine maleate CAS 3505-38-2On April 3, 2013 the FDA approved the new drug application carbinoxamine maleate, CAS number 3505-38-2, for the treatment of allergic rhinitis. Targeted for patients suffering from seasonal and perennial allergic rhinitis, the approval of carbinoxamine is a novel approach to allergy relief. Carbinoxamine is the first sustained-release histamine receptor blocking agent that is indicated to treat both perennial and seasonal allergies in patients two and older. Coined as the brand name Karbinal ER, this unique treatment is offered as a one-time dose every 12 hours. The ease of the liquid administration as an oral solution, plus the 12 hour extended relief makes this second-generation antihistamine quite attractive to allergy sufferers.

In addition to easing the symptoms of perennial and seasonal allergic rhinitis, carbinoxamine is also effectual for treating patients suffering from allergic conjunctivitis, vasomotor rhinitis, dermatographism, amelioration (severe allergic reaction to blood plasma), anaphylactic reactions (used in conjunction with epinephrine), and allergic skin reactions due to angioedema or urticaria. Adverse effects of carbinoxamine are mild and may include a sore throat and dry mouth, among other minor side effects. The advent of this form of carbinoxamine as a tasty flavored oral suspension appears to be valid distraction from potential side effects, however, particularly for children in need of consistent and effective treatment for allergies.

allergy-sneezeAccording to the Asthma and Allergy Foundation of America asthma and allergies strike one out of every five Americans. In addition, allergies are the 5th leading chronic disease in the United States; making the need for new and effective treatments urgent and essential. In 2010 roughly 10 percent of children in America were diagnosed with allergic rhinitis, or hay fever. The child and adolescent population is sure to appreciate this new carbinoxamine oral solution, especially with its easy dosing and flavored taste.

LGM Pharma provides carbinoxamine for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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