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"To comply with the order, the F.D.A. has asked the manufacturer of Plan B One-Step to submit a supplemental application seeking approval of the one-pill product to be made available O.T.C. without any such restrictions," the statement said.
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Biovest International (Tampa, FL, USA) recently submitted formal notification to the EMA informing of its intent to file a Marketing Authorization Application (MAA) seeking approval in the EU for its personalized cancer vaccine BiovaxID.
In an interview yesterday, Ms. Thompson said that Wal-Mart made the decision to withdraw the bank application late last week after seeking approval from H. Lee Scott, the company's chairman and chief executive.
Merck said it was on track to file an application seeking European approval this year.
The company said it would file its application seeking government approval for the drug, ranolazine, in the second half of next year.
This will be reflected in our upcoming application seeking the approval of the Federal Energy Regulatory Commission for this important energy facility.
The developer, CV Therapeutics of Palo Alto, Calif., said it would file its application seeking government approval for the drug in the second half of next year.
On 25 April 2007, he re-appeared in the news when he filed an application seeking court approval to be reinstated as a lawyer.
Exact Sciences, which is based in Madison, Wis., said it would soon complete its application to the Food and Drug Administration seeking approval of the Cologuard test.
Saying the F.D.A.'s generic drugs department was underfunded, Dr. Hamburg noted a potential remedy: placing application fees on companies seeking approval for generic drugs.
Allegheny said it had filed an application with the Securities and Exchange Commission seeking approval for an initial public offering of up to 18percentt of the common stock in the supply business.
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