FDA Weighs OTC Approval of Singulair
WASHINGTON (AP) — Federal health regulators are weighing the risks of permitting Merck to sell its prescription respiratory pill Singulair as an over-the-counter medicine for allergies.
In a review posted online, the Food and Drug Administration raises concerns that the drug could be used inappropriately by teenagers or by patients with more serious conditions, like asthma.
On Friday, the agency will ask a panel of advisers to vote on the drug's safety for nonprescription use.
Singulair, first approved in 1997, was once Merck's best-selling drug with revenue of $4.76 billion in 2011. But sales have plummeted since Singulair's patent expired mid-2012, exposing the brand to lower priced generic competition.
Merck hopes to give the drug a new life as an over-the-counter medication, competing alongside antihistamines pills like Claritin and nasal sprays like Nasacort.