Generic drug

Saturday Evening Post - Vol. 280 Nbr. 5, September 2008

Trouble switching to generic drug.

* Trouble Switching to Generic Drug: To S.M., N. Mankato, Minnesota: You report ...... Ativan to a generic version and have heard that drug manufacturers can reduce the strength of ...... Our nation's laws require that all drugs (both trade name and generic) meet the same ...

ColoradoBiz - Vol. 31 Nbr. 5, May 2004

FDA ok's atrix generic drug.

... Food and Drug Administration for Atrix's abbreviated new drug ...... This is the first approval for a generic version of the popular anti-acne medication. ...

US Code - Title 42: The Public Health and Welfare - January 20, 2006

42 USC 1396 - Sec. 1396r-8. Payment for covered outpatient drugs

... 1396b(a) of this title for covered outpatient drugs of a manufacturer, the manufacturer must have ...... requirements of paragraph (5) (with respect to drugs purchased by a covered entity on or after the ...

US Code - Title 21: Food and Drugs - January 19, 2006

21 USC 355 - Sec. 355a. Pediatric studies of drugs

... neonates in appropriate cases) in which a drug is anticipated to be used. (b) Market ...... that information relating to the use of a new drug in the pediatric population may produce health ...... months rather than three years; and (B) if the drug is designated under section 360bb of this title ...

United States Law Articles in English - (June 23, 2003)

Bush Proposal May Facilitate Generic Drug Entry

Dr. Yin Zhang PhD - Testa, Hurwitz & Thibeault, LLP

In October, 2002, President Bush issued proposed revisions to the FDA regulations governing generic drug market entry. The proposed regulations ("...... The proposed regulations ("The Availability Of The 30-Month Stay of FDA Approval Of Generic Drug Applications And Revised Orange Book Patent ...

State Journal, The - January 30, 2009

New Program Educates Elderly, Poor About Generic Drugs

Manufacturers of brand-name medications generally are given 20 years from the date of submission of their patents before their products can be duplicated by generic drug manufacturers, according to the U.S. Food ...

Federal Circuits - July 07, 2006

Mylan Pharmaceuticals, Incorporated, Plaintiff-Appellant, v. United States Food and Drug Administration; Lester M. Crawford, Acting Commissioner of the Food and Drug Administration, Defendants-Appellees, and Procter & Gamble Pharmaceuticals, Incorporated; Procter & Gamble Company; Watson Pharmaceuticals, Incorporated; Watson Laboratories, Incorporated, Defendants. Generic Pharmaceutical Association, Amicus Supporting Appellant., 454 F.3d 270 (4th Cir. 2006)

... Bradshaw, Associate General, Food and Drug Division, Eric M. Blumberg, Deputy Chief, ...... OPINION MICHAEL, Circuit Judge: The Food and Drug Administration (FDA) approved Mylan ......'s application to sell a generic version of a drug that Procter & Gamble Pharmaceuticals, Inc. sold ...

U.S. Supreme Court - March 22, 1983

United States v. Generix Drug Corp., 460 U.S. 453 (1983)

U.S. Supreme Court UNITED STATES v. GENERIX DRUG CORP., 460 U.S. 453 (1983) 460 U.S. 453 ...... Argued November 3, 1982 Decided March 22, 1983 The Federal Food, Drug, and Cosmetic Act (Act) prohibits the marketing ...

Federal Register, November 01, 2002

Human drugs: day generic drug exclusivity; withdrawn,

Proposed rules

...gov] [DOCID:fr01no02-32] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug 21 CFR Part [Docket No. 85N-......tion 21 CFR Part 314 85N-0214] 180-Day Generic Drug Exclusivity for Abbreviated New Drug AGENCY: Food and Drug ...

Code of Federal Regulations - Title 21: Food and Drugs - December 30, 2005

21 CFR 316.28 - Publication of orphan-drug designations.

TITLE 21 - FOOD AND DRUGS CHAPTER I - FOOD AND DRUG ADMINISTRATION, ...... D - DRUGS FOR HUMAN USE 316 - ORPHAN DRUGS subpart c - DESIGNATION OF AN ORPHAN 316.28 ...... Each month FDA will update a publically available list of drugs designated as orphan drugs. A cumulative, ...