Navigation Links
Hoping to Ease Shortage, FDA Fast-Tracks Generic Form of Cancer Drug
Date:2/4/2013

MONDAY, Feb. 4 (HealthDay News) -- Seeking to ease potentially dangerous shortages of a key cancer drug, the U.S. Food and Drug Administration on Monday announced it had fast-tracked the approval of the first generic form of one such medication, Doxil (doxorubicin).

"The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them," Capt. Valerie Jensen, director of the Drug Shortage Staff at the FDA's Center for Drug Evaluation and Research, said in an agency news release. "For the past year, the FDA has been working to ensure that supplies of [doxorubicin] were not interrupted."

The new generic version is made by Sun Pharma Global and will be available in 20 milligram and 50 milligram vials. Like brand-name Doxil, the injected drug is administered intravenously by a health care professional.

Generic drugs approved by the FDA have the same quality and strength as brand name drugs, and the generic manufacturing and packaging sites must pass the same quality standards as those of brand name drugs, the agency noted.

In response to the Doxil shortage, the FDA announced in February 2012 that it would allow temporary controlled importation of Lipodox, an alternative to Doxil that is produced by Sun Pharma Global but not approved in the United States.

The FDA also decided to allow the release of one lot of Janssen's Doxil made under an unapproved manufacturing process.

For the time being, the FDA said it will continue to allow the controlled importation of Lipodox. Once there is enough of Sun's generic version to meet projected demand, the FDA will halt imports of any unapproved doxorubicin product.

Shortages of potentially life-saving cancer medications have plagued the U.S. health care system for the past two years.

Speaking at the annual meeting of the American Society for Clinical Oncology last June, Dr. Richard
'/>"/>

Copyright©2012 ScoutNews,LLC.
All rights reserved  

Page: 1 2

Related medicine news :

1. Generic HIV treatment strategy could save nearly $1 billion annually but may be less effective
2. 1/3 of Docs Often Prescribe Brand-Name Drugs Over Generics: Study
3. People May Skip Generic Pills if Color Differs From Brand-Name Drug
4. Differences in generic pill characteristics may lead to interruptions in essential medication use
5. Inconsistency Seen in Safety Labeling for Generic Drugs
6. Regenstrief study finds that generic drugs often have incorrect safety labeling
7. FDA Pulls One Generic Form of Wellbutrin Off the Market
8. Toward competitive generic drug prices in Canada
9. Generic drugs key to US overseas HIV relief
10. FDA Approves Generic Versions of Plavix
11. Plavixs New Generic Status Could Be Boon for Patients
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Hoping to Ease Shortage, FDA Fast-Tracks Generic Form of Cancer Drug
(Date:7/12/2014)... The Passenger Information System market is estimated ... million by 2019, at an expected CAGR of 26.5% ... public transport infrastructure in North America is well developed ... every corner of the region. The growing ridership figures ... service providers are driving the North American Passenger Information ...
(Date:7/12/2014)... HealthDay Reporter SATURDAY, July 12, 2014 ... surgical technique used to grind up uterine growths and remove ... cancer to other parts of a woman,s body, U.S. health ... and Drug Administration also said that women who do undergo ... a written consent stating that they understand the potential risks, ...
(Date:7/12/2014)... July 12, 2014 The Security Analytics ... 2013 to $3,376.6 million by 2019, at an expected ... 2019. The challenges to counter the increasing number of ... of outdated cyber defense systems in organizations are enormous. ... and remodeling their existing architecture to develop better and ...
(Date:7/12/2014)... (HealthDay News) -- If you make exercise fun, you,ll eat ... experiment, 56 adults were led on a 1.4-mile walk and ... a scenic walk. The participants were given lunch after the ... outing ate 35 percent more chocolate pudding for dessert than ... In another experiment, 46 adults were given mid-afternoon snacks after ...
(Date:7/12/2014)... “After my mom’s stroke, she loss the use of her right ... of his left side. Eating became a difficult task for them ... them enjoy eating again,” said an inventor, from Fayetteville, N.C. As ... PLATE (P C H PLATE). , The PATRICIA CAROL HALL PLATE ... for individuals who suffer from stroke, experience tremors or loss of ...
Breaking Medicine News(10 mins):Health News:North America Passenger Information System (ICT) Market worth $5,486.88 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Passenger Information System (ICT) Market worth $5,486.88 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Passenger Information System (ICT) Market worth $5,486.88 Million by 2019 - New Report by MicroMarket Monitor 4Health News:FDA Advisers Weigh Risks of Procedure for Removal of Uterine Fibroids 2Health News:FDA Advisers Weigh Risks of Procedure for Removal of Uterine Fibroids 3Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 4Health News:Make Exercise Fun, Eat Less Afterwards 2
... COLUMBIA, Mo. Most people have witnessed otherwise intelligent ... intoxicated, but what specifically happens in the brain to ... effects on brain activity from the University of Missouri ... people when they are making a mistake, ultimately reducing ...
... September 1, 2011Scientists involved in DNA vaccine research are ... effective delivery systems and the development of more efficient ... Top investigators in the field recently discussed these and ... "DNA Vaccines: Building on Clinical Progress and Exploring New ...
... THURSDAY, Sept. 1 (HealthDay News) -- Most children need to get ... last year, the American Academy of Pediatrics says. The 2011-12 ... year,s vaccine, but a person,s immunity decreases by as much as ... it,s important for children to get another flu shot this year, ...
... --,Molecular signals from stem cells within the skin,s fatty layer ... to new treatments for baldness in people, researchers report. ... to talk to the dormant stem cells at the base ... hair to grow again," senior study author Valerie Horsley, an ...
... engineer? Sex hormones strongly influence people,s interests, which ... to psychologists. , "Our results provide strong support ... by working with things versus people," said Adriene ... Sheri A. Berenbaum, professor of psychology and pediatrics, ...
... THURSDAY, Sept. 1 (HealthDay News) -- The intensity of exercise, ... your chances of living a longer life, a new study ... that men with high levels of cycling intensity lived 5.3 ... longer, than men with low intensity. Among female cyclists, ...
Cached Medicine News:Health News:Alcohol dulls brain 'alarm' that monitors mistakes, MU study finds 2Health News:GEN reports on advances in DNA vaccine delivery and production 2Health News:Last Year's Flu Shot Won't Protect Kids This Season 2Health News:Mouse Study Could Give New Clues to Fighting Baldness 2Health News:Sex hormones impact career choices 2
(Date:7/10/2014)... 2014  Decision Resources Group finds that while ... specialists are willing to prescribe Durata,s Dalvance (dalbavancin) ... as OPAT, approximately two-thirds of the respondents reported ... hospital inpatients. However, our findings indicate that nearly ... on OPAT following hospital discharge, and most are ...
(Date:7/10/2014)... 2014 Decision Resources Group finds that over ... Food and Drug Administration,s (FDA) approval of Vifor Fresenius ... was approved by the FDA in November 2013 for ... patients on dialysis. Other key findings from ... 2014 : , ...
(Date:1/15/2014)... Jan. 15, 2014 Most osteoporosis patients want a ... recent online survey* sponsored by Mission Pharmacal Company. The ... Osteoporosis Foundation online support community, revealed that 74 percent ... comes in a form other than a pill or ...
Breaking Medicine Technology:Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 3Half of Surveyed Nephrologists Report Moderate Familiarity with Velphoro, Which Received FDA Approval Late Last Year for the Treatment of Hyperphosphatemia in Dialysis 2Half of Surveyed Nephrologists Report Moderate Familiarity with Velphoro, Which Received FDA Approval Late Last Year for the Treatment of Hyperphosphatemia in Dialysis 3Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 2Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 3
... 12, 2011 Although medical devices possess strong ... medical device companies to invest more resources in ... products.   Tactical marketers in medical ... as troubleshooting post-launch and managing product enhancements, but ...
... Aug. 12, 2011 PLC Systems Inc. (OTCBB: PLCSF), ... reported financial results for the three- and six month ... the company,s RenalGuard® operations, since PLC completed the sale ... during the first quarter of 2011. Results from the ...
Cached Medicine Technology:Medical Device Marketing Groups Focus More Resources on Tactical Activities When Compared to Pharmaceutical Counterparts 2PLC Systems Reports Second Quarter 2011 Results 2PLC Systems Reports Second Quarter 2011 Results 3PLC Systems Reports Second Quarter 2011 Results 4PLC Systems Reports Second Quarter 2011 Results 5PLC Systems Reports Second Quarter 2011 Results 6
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: