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U.S. Department of Health and Human Services

Drugs

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May 7: I have been taking Singulair since its release and feel that I am being penalized because of a new patient use that extends exclusivity and prevents a generic version from being approved. I truly feel that FDA is more concerned with the drug companies than the people taking these medications.

CDER Director's Mailbag

FDA approved the first generic versions of Singulair on August 3, 2012 for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies. For people who suffer from chronic health conditions such as asthma and allergies, this approval expands effective and affordable treatment options.