Generic Drugs: They Save Money. But, Are They Safe? About.com - Drugs, NY - Nov 26, 2008 ... while the generic version, Sertraline HCl, cost $15.00 for a 30-day supply ? a savings of $85.00! The US Food and Drug Administration (FDA) is ...
More Study Is Needed for Off-Label Use of Drugs, Study Says eFluxMedia - Nov 25, 2008 Rounding the list were: depression drugs bupropion (Wellbutrin), sertraline (Zoloft), venlafaxine (Effexor), duloxetine (cymbalta), trazodone (desyrel), ...
Novel Treatment Approaches for Refractory Anxiety Disorders Focus (subscription) - Nov 18, 2008 Of 128 patients with PTSD who did not respond to an acute 12-week trial of sertraline, 54% converted to responders during a subsequent 24-week continuation ...
Recent News and Articles on the Keywords: fda + approves + generic Related to the article below (Last Update: 8/5/2008)
Pfizer spent nearly $3.1 million lobbying in 2Q Forbes, NY - Lawmakers approved the agreement with Peru late last year. Pfizer (nyse: PFE - news - people ) also lobbied on bills to allow generic drug companies to sell ...PFE
Salix may get more pressure from generics Trading Markets (press release), CA - The losses the company projected for the rest of the year could deepen if the FDA also approves generic versions of MoviPrep and OsmoPrep, liquids patients ...SLXP - OTC:CMTX
UPDATE 2-Generic drug backlog to grow-US FDA official guardian.co.uk, UK - Jul 30, 2008 "We have a shared goal to ensure that (the FDA) has sufficient resources to approve generic applications in a timely manner. It benefits everyone," she said ...
Mylan Launches Generic Hypertension Drug FDA news (subscription), VA - Aug 4, 2008 In January, the FDA approved formulations of Sular in 8.5-, 17-, 25.5- and 34-mg strengths. The new Sular formulation uses SkyePharma?s Geomatrix technology ...
Animal Drug Review Laws Approved Farm Futures, IL - Aug 3, 2008 AGDUFA will do the same for generic animal drugs. The laws will require animal health companies to report to FDA by March 31 of each year certain data ...
GlaxoSmithKline spent $1.8M lobbying in 2Q Forbes, NY - Aug 4, 2008 Generic drug companies already market cheaper versions of regular, chemical drugs, but the FDA does not have the authority to approve copies of biotech ...GSK
Source: Google News
Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999 - J Cross, H Lee, A Westelinck, J Nelson, C … - Pharmacoepidemiology and Drug Safety, 2002 - doi.wiley.com ... Available at: http://www.fda. ... APPENDIX 1: LISTING OF NMES APPROVED 1980?1999
EXPERIENCING A DOSAGE ...Generic Approval Time to Type of Approved indication ...
Drug patent expirations and the speed of generic entry - JP Bae - Health Services Research, 1997 - pubmedcentral.nih.gov ... rights expiration dates: Food and Drug Administration's (FDA) Approved Drug Products
with Therapeutic Equivalent Evaluations (1986-1989). Generic entry dates ...
Paclitaxel production in suspension cell cultures of Taxus - REB Ketchum, DM Gibson - Plant Cell, Tissue and Organ Culture, 1996 - Springer ... ic yew) is the only FDA-approved source of pacli- taxel for clinical use, although
the FDA is consider ... The approvedgeneric name for the drug is paclitaxel. ...
Regulatory Agency Discretion among Competing Industries: Inside the FDA - MK Olson - Journal of Law, Economics, and Organization, 1995 - Oxford Univ Press ... demand for regulatory services influences FDA approval activity. ... may take less time
to approve, pre&AREC andpost ... limited resources could have approved the same ...
Generic Drug Industry Dynamics - D Reiffen, MR Ward - Review of Economics and Statistics, 2005 - MIT Press ... reduced the regulatory burden for generic produc- ers by requiring only that they
demonstrate bioequivalence to a drug that was already approved by the FDA. ...
Generic Substitution and Optimal Patient Care - JE Murphy - Archives of Internal Medicine, 1999 - Am Med Assoc ... All rights reserved. Page 5. problemswithsubstitution,and2ofthearticlesquoted
11,16 do not relate to substitution of FDA-approvedgeneric equivalents. ...
Understanding bioequivalence testing - LZ Benet - Transplantation Proceedings, 1999 - Elsevier ... It has been reported that the FDA is currently reanalyzing over 2000 generic drug
products that have been approved since the 1987 evaluation. ...
As part of the Food and Drug Administration's (FDA) on-going efforts to increase the available generic drug alternatives for American consumers, the agency today approved the first generic version of Zoloft tablets (sertraline), as well as a liquid concentrate (sertraline hydrochloride) version of the product.
Sertraline tablets are indicated for the treatment of major depressive disorder (MDD) in adults and the liquid concentrate is approved for the treatment of MDD and some anxiety related disorders. In 2005, Zoloft was the sixth highest-selling brand-name drug in the United States, with retail sales totaling $2,561,069,000.
"Generic drugs are safe and effective alternatives to brand name prescription products and can provide for significant cost savings for the American public," said Gary J. Buehler, Director, Office of Generic Drugs. "Our office is committed to increasing the number of approved generic alternatives as quickly as possible."
The economic benefits of FDA's generic drug approval program are significant because generics can cost a fraction of the price of the brand name drugs and generic drugs represent about two-thirds of total prescription doses sold in the United States in 2004, according to IMS data on U.S. retail sales. Competition from generic drugs that are safe and effective alternatives may quickly lead to reductions in spending. The savings would likely increase as more competitors enter the market (See http://www.fda.gov/cder/ogd/generic_competition.htm).
FDA's Office of Generic Drugs (OGD) continues working expeditiously to review and take action on generic drug applications. For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm.
