Drugstore Rebate Report: November 2008 In-Store Marketing Institute (subscription), IL - Nov 30, 2008 ... an ad for Eli Lilly's KwikPen insulin injector; a feature listing blood glucose monitoring tips from the chain's Joslin Diabetes Center; and a message ...
Feds deal a setback to new Byetta version Indianapolis Star, United States - Nov 6, 2008 Byetta is a popular biotech drug to treat diabetes, used by people who do not yet take insulin. The standard version of the drug, launched three years ago, ...
Patient Safety With Injectables Medscape - Nov 25, 2008 These errors include using the wrong drug (insulin mistaken for saline IV flush), incorrect drug concentrations (concentrated heparin used to flush IV ...
Pfizer's Ills And Cures In 2008 Trading Markets (press release), CA - Nov 22, 2008 As generic drugs are priced 25% to 70% lower than their brand-name equivalents, sales of branded drugs get eroded when generic copies are introduced. ...
Op-Ed Contributor The Wrong Message in a Bottle New York Times, United States - Nov 14, 2008 In 1988, Ms. Akunyili?s sister died from taking fake insulin to treat her diabetes. Imports of bad medicines like those seized in Belgium are only part of ...
Diabetes drug costs soaring, top $12 billion last year Austin American-Statesman, TX - Nov 4, 2008 In one, University of Chicago and Stanford University researchers looked at the total costs of the pills and insulin that doctors prescribed. ...
Medicis Reports Second Quarter 2008 Financial Results MarketWatch - Aug 5, 2008 This decrease is due to the $25 million payment to Ipsen for the RELOXIN(R) BLA acceptance by FDA. The Company's achievement of approximately $132.5 million ...MRX
FDA Approves Depakote to Treat Epileptic Seizures, Migraine? eFluxMedia - Jul 30, 2008 By Alice Carver The US Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium), ...
Health Winners & Losers: Amgen TheStreet.com - Jul 28, 2008 The FDA requested an efficacy study that could take up to a year and a half and cost $35 million, as well as additional long-term safety data that could ...AMGN
Lawsuits claim Seroquel marketed to doctors illegally The News Journal, DE - Aug 3, 2008 Quetiapine, the generic name for Seroquel, emerged from the Fairfax laboratory of the British firm ICI, which spun off its pharmaceutical and biosciences ...
Glaxo Names New General Counsel Wall Street Journal - Jul 22, 2008 Mr. Troy managed FDA agency litigation from 2001 to 2004. Under Mr. Troy, the agency began filing amicus briefs opposing lawsuits against drug and medical ...
Safety Concerns Raised About Some Generic Drugs KTVU.com, CA - Jul 25, 2008 Consumer watchdog Jerry Flanagan says the FDA and state regulators are outmatched: "The problem is that the FDA that's supposed to be overseeing generic and ...
Source: Google News
Lower phenytoin serum levels in persons switched from brand to generic phenytoin - RT Burkhardt, IE Leppik, K Blesi, S Scott, SR … - Neurology, 2004 - AAN Enterprises ... PHT concentrations from brand to generic or generic to brand ... report indicate that
changes in the steady-state extent of ... mg doses of PHT in the FDA test process ...
Comparative Bioavailability of a Generic Phenytoin and Dilantin - DH Rosenbaum, AJ Rowan, L Tuchman, JA French - Epilepsia, 1994 - Blackwell Synergy ... The 19.3% difference in steady-state blood levels is within the FDA... content of 94.5%
of the stated 100 mg (FDA, 1988), a ... (1990) between the generic and brand ...
Comparison of Steady-State Blood Levels of Two Carbamazepine Formulations - A Jumao-as, I Bella, B Craig, J Lowe, RM Dasheiff - Epilepsia, 1989 - Blackwell Synergy ... products were rated AB by the FDA, which indicates ... on drug metabolism and
steady-state plasma concentration ... efficacy of brand-name and generic CBZ preparations ...
Generic Substitution SL Nightingale - JAMA, 1998 - Am Med Assoc ...Generic Substitution: The FDA has asked health ... of its position on generic substitu-
tion.TheFDAhasbeenreceivinginquir- ies from state legislatures, state...
Is Generic Prescribing Acceptable in Epilepsy? - FMC Besag - Drug Safety, 2000 - drugsafety.adisonline.com ... Rosenbaum et al.[20], the generic formulation in ... was consequently not possible to state whether the product still fulfilled the FDA requirements, although ...
Digoxin bioavailability: evaluation of a generic tablet and proposed FDA guide. lines - WG Kramer, AJ Kolibash, MS Bathala, JA Visconti, … - J Pharm Sci, 1977 - doi.wiley.com ...generic digoxin tablet; A, current market standard tablet; and D ... The FDA has taken
a major step forward by ... College of Pharmacy, Ohio State University, Columbus ...
Generic Substitution and Optimal Patient Care - JE Murphy - Archives of Internal Medicine, 1999 - Am Med Assoc ... trial of its product vs the proposed generic one instead of lobbying state legislatures,
spon ... efforts focus on continuing to work with the FDA to change ...
Buy some today Can generics be safely substituted for brand-name drugs? - RP Lesser, G Krauss - Neurology, 2001 - AAN Enterprises ... Available at: http://www.fda.gov/cder/news ... Comparison of steady-state blood levels
of two ... Comparative bioavailability of phenytoin from generic formulations in ...
Trends of generic substitution in community pharmacies - DC Suh - Pharmacy World & Science, 1999 - Springer ... a product to be considered as an acceptable generic substitute, and ... must have been
turned in to the FDA, and the ... must meet all current Federal and State Laws. ...
Source: Google Scholar
States petition US FDA on generic insulin, hormone
Four governors, looking to ease drug costs under state programs, petitioned the U.S. Food and Drug Administration on Thursday to provide guidelines for generic versions of insulin and human growth hormone.
The FDA has been developing regulatory advice for companies who want to make cheaper copycat versions of the injectable drugs since 2001, but recently delayed issuing final guidelines.
In their petition, the governors joined other critics in accusing the agency of dragging its feet.
"We have been informed that there are no scientific reasons for delaying the issuance of the guidance documents FDA already has drafted," the bipartisan group of governors wrote the FDA.
Democratic Govs. Kathleen Sebelius of Kansas and Jim Doyle of Wisconsin joined Republicans Tim Pawlenty of Minnesota and James Douglas of Vermont in signing the petition.
"There is no legal or regulatory obstacle to the immediate issuance of these guidance documents," they added.
Both insulin, used to treat diabetics, and growth hormone, used to treat growth disorder, are protein-based drugs known as biologics.
With a growing number of diabetics in the Unites States and tightening state budgets, the governors are eager for cheaper insulin alternatives.
"The FDA's delay in informing manufacturers of the requirements for obtaining approval of therapeutically equivalent versions of insulin and HGH has cost the states and other health-care providers hundreds of millions of dollars," the petition said.
About 7 percent of Americans, or nearly 21 million people, have diabetes, according to the National Institutes of Health. Growth disorders are more difficult to measure. Not all those diagnosed with either condition are treated.
Many states pay for prescription drugs through the joint federal-state Medicaid program for the poor as well as special insurance programs for children.
Because insulin and growth hormone were approved decades ago as regular drugs, supporters argue the FDA has the legal authority to approve generic versions.
The issue of cheaper alternatives to other biological drugs remains in limbo. Brand name companies say biologics are too complicated to copy.
In May, the agency approved a generic version of human growth hormone made by Novartis AG's Sandoz unit called Omnitrope but said the decision did not set any precedent for other biologics.
The FDA did not have immediate comment on the petition.
The Generic Pharmaceutical Association supported the governors' move as a way to force the FDA's hand. The Biotechnology Industry Organization, which represents brand name makers, did not have immediate comment.
