FDA OKs re­turn of Pri­matene Mist in­haler

Belleville News-Democrat - - News - BY LINDA A. JOHN­SON

A new ver­sion of the once-pop­u­lar asthma in­haler Pri­matene Mist will soon re­turn to U.S. stores.

The Food and Drug Ad­min­is­tra­tion ap­proved the over-the-counter aerosol in­haler late Wed­nes­day. It’s for tem­po­rary re­lief of mild, in­ter­mit­tent asthma symp­toms in peo­ple ages 12 and up.

The orig­i­nal Pri­matene Mist was dis­con­tin­ued seven years ago be­cause the in­haler’s ozone-de­plet­ing pro­pel­lant had been banned. That ver­sion had been mar­keted for half a cen­tury, in­clud­ing in mem­o­rable TV ads.

The new prod­uct de­vel­oped by Am­phastar Phar­ma­ceu­ti­cals uses a safer pro­pel­lant. The in­haler will cost about $25 and con­tain 160 doses. It should be avail­able by the end of the year.

“Res­cue in­halers” are meant to quickly re­lieve asthma symp­toms such as wheez­ing, cough­ing, short­ness of breath and chest tight­ness, which can be trig­gered by pollen, mold, dust mites, pet dan­der, stress or ex­er­cis­ing in the cold.

Pri­matene Mist’s ac­tive in­gre­di­ent, the hor­mone ep­i­neph­rine, re­laxes mus­cles in the lungs to in­crease air­flow. The prod­uct is the only FDA-ap­proved over-the-counter in­haler. Nu­mer­ous pre­scrip­tion res­cue in­halers, con­tain­ing the medicine al­buterol or lev­al­buterol, are avail­able.

In a state­ment Thurs­day, FDA of­fi­cials noted con­cerns that some peo­ple may in­ap­pro­pri­ately use or overuse the new in­haler. The agency said it should not be sub­sti­tuted for pre­scrip­tion treat­ments or used by peo­ple with se­vere asthma.

Pri­matene Mist was pulled from stores in 2011.

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