First generic versions of singulair approved

(HealthDay) -- The first generic versions of Singulair (montelukast sodium) have been approved by the U.S. Food and Drug Administration.

The product is not meant to treat sudden onset of serious , the FDA warned, but it does treat asthma and hay fever symptoms by blocking substances in the body called leukotrienes, the agency said Friday in a news release.

The FDA said the product could cause serious side effects, including behavioral or mood changes, depression, hallucinations, , or feeling numbness in the extremities. Anyone who has these symptoms should immediately see a physician, the agency said.

Less serious but more common adverse reactions could include: fever, headache, sore throat, cough, stomach pain, diarrhea, ear ache or runny nose.

Approval to produce generic tablets, generic chewable tablets or both versions was granted to: Apotex Inc., Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland Inc., Mylan Inc., Roxane Laboratories, Sandoz Inc., Teva ., and Torrent Pharmaceuticals, the FDA said.

The agency stressed the generic drugs it approves are equal in strength and quality to their brand-name counterparts.

Brand-name Singulair, made by Merck & Co., was approved by the FDA in 1998.

More information: Medline Plus has more about this drug.

add to favorites email to friend print save as pdf

Related Stories

Generic versions of plavix approved

May 18, 2012

(HealthDay) -- The first generic versions of Plavix (clopidogrel bisulfate) have been approved by the U.S. Food and Drug Administration.

Generic boniva approved for osteoporosis

Mar 19, 2012

(HealthDay) -- The first generic versions of the once-monthly osteoporosis drug Boniva (ibandronate) have been approved by the U.S. Food and Drug Administration.

First generic lexapro approved

Mar 14, 2012

(HealthDay) -- The Israeli drug maker Teva Pharmaceuticals has gained the first U.S. approval to market generic Lexapro (escitalopram) to treat depression and general anxiety disorder, the U.S. Food and Drug Administration ...

Generic pediatric AIDS Drug gets U.S. OK

Jun 28, 2006

The U.S. Food and Drug Administration has tentatively approved the generic version of Abacavir Sulfate Oral Solution for use by pediatric AIDS victims.

Recommended for you

Seaweed menace may yield new medicines

8 hours ago

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

Supercomputers link proteins to drug side effects

Oct 20, 2014

New medications created by pharmaceutical companies have helped millions of Americans alleviate pain and suffering from their medical conditions. However, the drug creation process often misses many side ...

User comments