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Biovail Corporation (NYSE:BVF)(TSE:BVF), Toronto, has announced that its 30mg dosage strength of generic Procardia XL (once daily nifedipine) has been granted final approval by the Food and Drug Administration (FDA) for immediate marketing in the United States.
Final approval for advanced exploration expected in November
If the new regulations receive final approval from the council, they would apply in the April 1997 elections for the City Council, the school board, the city clerk and the city treasurer.
Final approval is expected upon expiry of patent protection for the brand product on December 29, 2007.
Such status provides significant advantages and assistance to Biovest in getting final approval to market BiovaxID(TM) in the EU.
The closing is subject to the final approval of the FTC and the EC, and details of the transaction will be disclosed after final approval.
Final approval is expected upon the earlier of a favorable decision in the case or expiry of the mandatory stay of approval in August 2007.
Food and Drug Administration (FDA) to refrain from issuing a final approval for Teva's Abbreviated New Drug Application (ANDA) for generic pravastatin 10, 20 and 40 mg strengths until after 5:00 pm on Friday, April 21, 2006, in order to give Apotex an opportunity to appeal today's ruling in favor of Teva.