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

Health care M&A leads global deal surge

Nov 23, 2014

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and ...

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.