Merck (NYSE: MRK) has received full letters from the US Food and Drug Administration for an verbal preventive and eye treatment drug it markets in non-US countries it disclosed in a filing with the Securities and Exchange Commission, an denote that the FDA has declined to authorize the drug , according to Reuters.
The Whitehouse Station, New Jersey curative company’s verbal preventive Nomac/E2 is sole in Europe as Zoely and its glaucoma treatment drug, tafluprost, is sole in 9 countries . It protected the rights to tafluprost from Japanese drugmaker Santen Pharamaceutical Co.
A Merck orator told Bloomberg : “‘The firm skeleton to have serve discussions with the FDA. We are not getting in to any of the specifics of what was in the letter.’
In July Merck received a full reply e-mail from the FDA for its drug Janumet XR, an lengthened let go chronicle of its diabetes drug Janumet, scored equally to “pre-approval review issues,” according to the SEC filing. Merck mentioned that it has responded to the questions lifted by the US regulator and expects a reply in the initial entertain of 2012.
Separately, the FDA granted Merck’s single-rod hormonal contraceptive, Nexplanon . The device is extrinsic in a woman’s arm underneath the skin to stop conceiving physically for up to 3 years.
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