Nov 9 The U.S. Food and Drug Administration has
declined to approve an oral contraceptive and a glaucoma
treatment being developed by Merck & Co Inc , but the
U.S. drugmaker did not disclose details of the agency's
Merck already sells both products in some overseas markets.
The contraceptive, called NOMAC/E2, is a pill that combines two
hormones. The glaucoma medicine, tafluprost, is also known by
its brand name Saflutan.
Merck buried mention of the two U.S. setbacks in a 62-page
regulatory filing with the U.S. Securities and Exchange
Commission, saying it received so-called complete response
letters from the FDA for both products.
Such letters indicate the FDA is not yet willing to approve
an experimental product and often cite shortcomings of the
product or the agency's need for more clinical trial data or
additional analysis of such data. Drugmakers are not required
to share such details with the public or with stockholders.
Merck did not issue news releases about the FDA refusals,
but instead briefly noted them two thirds of the way into the
Drugmakers typically issue news releases announcing
complete response letters, with varying levels of detail about
FDA concerns or requirements.
"We're not commenting beyond what's been disclosed" in the
complete response letters, a Merck spokesman said, noting the
company plans to have further discussions with the FDA in
regard to the letter.
Merck said it received the complete response letter
regarding the contraceptive on Nov. 4, three days before the
letter involving its glaucoma medicine.
The setbacks come just a day ahead of Merck's annual
meeting at company headquarters with analysts and money
managers, to review its pipeline of experimental products.
Merck also noted in the filing that it had discontinued
development of MK-0431C, a pill pairing Merck's Januvia
diabetes drug with the active ingredient of Actos
(pioglitazone), a diabetes treatment sold by Takeda
Pharmaceutical Co Ltd .