NEW TEXTS THIS WEEK - Drug Information Association

made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human biological product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; IRESSA (Notice), 21-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
IRESSA and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a p atent which
claims that human drug product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; MYOZYME (Notice), 25-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
MYOZYME and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human biological product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; ORENCIA (Notice), 23-May-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
ORENCIA and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human biological product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; PREZISTA (Notice), 25-MAY-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
PREZISTA and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human drug product.
USA - Federal Register: Determination of Regulatory Review Period for Purposes of
Patent Extension; SOMAVERT (Notice), 24-may-2007
The Food and Drug Administration (FDA) has determined the regulatory review period for
SOMAVERT and is publishing this notice of that determination as required by law. FDA has
made the determination because of the submission of an application to the Director of
Patents and Trademarks, Department of Commerce, for the extension of a patent which
claims that human drug product.
USA - Federal Register: Draft Guidance for Industry and Review Staff on Labeling
for Human Prescription Drugs - Determining Established Pharmacologic Class for
Use in the Highlights of Prescribing Information; Availability (Notice), 16-May-
2007
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance
for industry and review staff entitled ‘‘Labeling for Human Prescription Drugs—Determining
Established Pharmacologic Class for Use in the Highlights of Prescribing Information.’’
(70103)This guidance is intended to help applicants and the review staff in ... (Abstract
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