Navigation Links
Spear Pharmaceutical Inc.'s ANDA for Fluorouracil Cream 5%
Date:5/20/2008

NEW YORK, May 20 /PRNewswire/ -- Spear Pharmaceuticals, Inc. received FDA approval for, and began shipping, Fluorouracil Cream 5%, USP, a generic equivalent to Valeant's Efudex(R) Cream. On April 11, 2008, the FDA approved the ANDA (Abbreviated New Drug Application) based on Spear's 318 patient study proving bioequivalence to Efudex(R) for the precancerous Actinic Keratoses (AK) skin condition, the indication for which the product is overwhelmingly prescribed (approximately 98% of patients). The product is also useful in the treatment of superficial basal cell carcinoma (sBCC).

Since December 2004, Valeant Pharmaceuticals has taken action to make it far more difficult for any generic Efudex(R) product to gain FDA approval (Efudex(R) was first approved in 1970 and has been off patent for 20 years.) Specifically, Valeant filed in December, 2004 a Citizen Petition that delayed the approval of the Spear generic product from the industry average of 16.6 months to 39 months.

Following this 39-month review, on April 11, 2008 (the same day the Spear ANDA was approved) Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research, notified Valeant in a detailed 11-page document that FDA had carefully considered its arguments, and decided to approve the Spear product, confirming that the Spear product is bioequivalent to Efudex(R) Cream. In explaining FDA's decision to approve, Dr. Woodcock writes " ... even when clinical trials are needed, it has not been the Agency's policy to require that bioequivalence be shown in every indication if drug release from the dosage form and appearance at the site or sites of activity has been demonstrated ... Therefore, if a study demonstrated efficacy for a topical 5-FU formulation to treat AK, this would provide assurance that the formulation would penetrate the skin sufficiently to treat sBCC." Dr. Woodcock further points out "The courts have expressly upheld FDA's regulatory implementation of the Act'
'/>"/>

SOURCE Spear Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Running Pioneer Kathrine Switzer Will Headline Women on the Move Conference August 13-15, 2008 in Spearfish, SD
2. 4-Star Gen. Barry McCaffrey, Former U.S. Drug Czar, and Dr. Barry Karlin, Nations #1 Drug Treatment Provider, to Spearhead Drug Treatment WVA Advocacy Day Feb 13-14; 142,000 Need, Dont Get Treatment in State
3. Britney Spears: Lets Talk About All of Us
4. Bellevue Dentist Gives a Thumbs Up to Britney Spears Smile
5. Caraco Pharmaceutical Laboratories, Ltd. to Announce Fourth Quarter and Fiscal Year 2008 Results on May 29, 2008
6. Tianyin Pharmaceutical Signs Over 60 New Distribution Agreements with 15 Regional Distributors
7. Jeffrey S. Williams Rejoins Alexza Pharmaceuticals as President, Alexza Singapore Pte. Ltd.
8. Global Pharmaceutical Launches: Best Practices for Winning Product Launch Successes
9. Genesis Pharmaceuticals Donates Medicine to China Sichuan Earthquake Relief
10. Shengtai Pharmaceutical, Inc. Reports Third Quarter Results of Fiscal Year 2008
11. Jazz Pharmaceuticals to Present at Investor Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/25/2014)... 24, 2014 (HealthDay News) -- Not getting the right ... colitis, a new study suggests. Those who sleep ... hours per night may be more prone to developing ... researchers report. The study authors concluded that duration and ... among patients with inflammatory bowel diseases. "Both short ...
(Date:10/25/2014)... Oct. 23, 2014 (HealthDay News) -- Current osteoporosis ... younger postmenopausal women at risk for osteoporosis-related fractures, ... to prevent fractures, we need tools that help ... injuries so that we can target these at-risk ... Crandall, professor of medicine in the division of ...
(Date:10/22/2014)... 22, 2014 At a time when ... parents and athletes at all levels, the UPMC ... the current discussion where two powerful messages are lost: ... that result in full recoveries every day. , In ... in fact and research, UPMC and the Concussion Program ...
(Date:10/22/2014)... 2014 Medical Solutions , ... happy to announce that our co-founder and CFO, ... Analysts’ Staffing 100 for 2014. Anderson was also ... influential people in the staffing industry,” in 2013.     ... 13th-largest healthcare staffing company in the U.S., was ...
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. 21, ... Ebola cases in Dallas. But, mental health specialists say overblown ... President Barack Obama on Friday appointed an Ebola "czar" to ... two Dallas nurses who cared for a Liberian man who ... But the U.S. cases are miniscule in the context ...
Breaking Medicine News(10 mins):Health News:Sleep Duration Linked to Ulcerative Colitis Risk in Study 2Health News:Osteoporosis Screening Guidelines May Miss Younger Women at Risk 2Health News:University of Pittsburgh Medical Center Launches Initiative to Emphasize Concussions Are Treatable 2Health News:University of Pittsburgh Medical Center Launches Initiative to Emphasize Concussions Are Treatable 3Health News:University of Pittsburgh Medical Center Launches Initiative to Emphasize Concussions Are Treatable 4Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 2Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 3Health News:Ebola Anxiety: A Bigger Threat Now Than the Virus Itself 2Health News:Ebola Anxiety: A Bigger Threat Now Than the Virus Itself 3
... capture school,portraits for years to come. However, most teens ... prefer to erase -- and replace. To encourage,teens to ... to,kick-off the launch of the CLEAN & CLEAR(R) Advantage(R) ... to,"Erase Their Worst Year Book Picture" at a pop-up ...
... 15 When we hear somebody,described as "frosty" or ... antisocial. There are numerous examples in our daily,language of ... such as loneliness, despair and sadness. We are taught ... descriptive and are not supposed to be,taken literally. However, ...
... Human Services ... Academic Excellence Award, SEATTLE, Sept. ... and its new innovative center, Partners for Our,Children (POC) has ... the recipient of the 2008 Academic Excellence Award., "The ...
... for Global Health (HIGH) has been selected to receive ... from the National Institutes of Health,s Fogarty International Center., ... additional $300,000 grant from the University and support HIGH,s ... The grant will fund the Fostering Opportunities for Nutrition ...
... Notes, NEW YORK, Sept. 15 Cell Therapeutics, ... MTA: CTIC) today announced,that a single institutional investor has ... Senior Notes due 2012, with a,conversion price of $1.27 ... to,price, volume and other requirements exercisable no later than ...
... child who receives an antipsychotic medicine is first prescribed ... olanzapine and risperidone. However, there has never been evidence ... first-generation medications., ,Now a study from the University of ... that molindone, a first-generation drug, is as effective as ...
Cached Medicine News:Health News:CLEAN & CLEAR(R) Is Inviting Teens to 'Erase Their Worst Yearbook Picture' With The NEW CLEAN & CLEAR(R) Advantage(R) Blackhead Eraser(TM) Exfoliating Cleanser 2Health News:Cold and Lonely: Does Social Exclusion Literally Feel Cold? 2Health News:Cold and Lonely: Does Social Exclusion Literally Feel Cold? 3Health News:University of Washington School of Social Work and Partners for Our Children Awarded Top National Recognition 2Health News:University of Washington School of Social Work and Partners for Our Children Awarded Top National Recognition 3Health News:Harvard University recipient of Global Health Nutrition grant 2Health News:Cell Therapeutics, Inc. Announces Single Institutional Investor to Purchase Up to $18 Million of Senior Convertible Notes 2Health News:Cell Therapeutics, Inc. Announces Single Institutional Investor to Purchase Up to $18 Million of Senior Convertible Notes 3Health News:First generation antipsychotic drugs as effective as newer ones in some children 2Health News:First generation antipsychotic drugs as effective as newer ones in some children 3
(Date:10/25/2014)... ARBOR, Mich. , Oct. 24, 2014 Advanced ... second quarter (ending September 26, 2014) financial results on Monday, ... will be released after the close of the market and ... discuss the results at 4:30 p.m. EDT on the same ... Richard Kurtz (CEO and Director), Rob Risser ...
(Date:10/25/2014)... Oct. 24, 2014  In 2008, two of Dr. ... of multiple controlled substances, on a regular basis, that ... that Dr. Gurney was practicing "all the time" while ... of his employees said that Dr. Gurney was prone ... patients." Dr. Gurney,s behavior became increasingly erratic ...
(Date:10/25/2014)... HILL, N.C. , Oct. 24, 2014 /PRNewswire/ ... to provide Medical Affairs leaders with a forum ... face. The consortium has developed a mechanism for ... discussions where leaders discuss key findings from the ... Practices has completed the analysis for the first ...
Breaking Medicine Technology:Advanced Photonix to Webcast Fiscal 2015 Second Quarter Earnings 2Doctors That Harm: The Real Stories Insurance Companies Against Prop 46 Don't Want You To Know, Part 8 of Consumer Watchdog Campaign Series 2Doctors That Harm: The Real Stories Insurance Companies Against Prop 46 Don't Want You To Know, Part 8 of Consumer Watchdog Campaign Series 3Strong Participation in Best Practices' Medical Affairs Consortium Survey 2
... company at the forefront of immunology treatment and research, is ... Washington, D.C. by reinforcing its commitment to improving the lives ... a large body of UCB data will highlight the potential ... Crohn,s disease. "ACG is an opportunity for UCB ...
... Zimmer Holdings, Inc. (NYSE and SIX: ZMH), a ... be participating in the 2011 Credit Suisse Annual Health ... in Phoenix, Arizona on November 9, 2011, at 8:00 ... of the presentation can be accessed via Zimmer,s Investor ...
Cached Medicine Technology:UCB Proudly Reinforces Long-Standing Commitment to Patients and Physicians at American College of Gastroenterology 2011 Annual Scientific Meeting 2UCB Proudly Reinforces Long-Standing Commitment to Patients and Physicians at American College of Gastroenterology 2011 Annual Scientific Meeting 3Zimmer Holdings to Present at 2011 Credit Suisse Annual Health Care Conference 2
Includes conservation device, matched regulator, standard supply tubing, cannula, carrying case, batteries, and instruction booklet....
... Control Catheter with Accutrol is similar in ... except that it incorporates a temperature probe ... The temperature probe can accurately determine the ... catheter provides temperature accuracy comparable to a ...
... Insertion Through A 1.0mm Incision., ,Special Direct ... ... Comfortable Approach., ,Recessed Jaws For Improved Sub-Incisional ... Of Jaws During Sterilization., ,Reusable, Autoclaveable, Guaranteed ...
... Spatula Tips That Mimic Corneal Curvature. Designed To ... Created With The IntraLase TMFS Laser System., ... Of The Forceps Are Designed To Facilitate Access ... Achieved, The Cross-Action Forceps Design Allows The Surgeon ...
Medicine Products: