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's bioequivalence requirements." Like thousands of generic drugs that have been approved over the years, the FDA approved the Spear product based on precedent and pursuant to its well established scientific, medical, and statistical review procedures for determining bioequivalence.

Despite this very clear position of the FDA, and the fact that the Courts do not overrule the FDA on matters of science, Valeant, in a further effort to block generic competition, sued the FDA asking the court to substitute its scientific judgment for that of the FDA.

Because of certain administrative issues regarding the FDA's record, Spear has voluntarily agreed not to ship additional product until the end of May, at which time we fully expect that the FDA will resolve its administrative issues and Spear shipments of Fluorouracil Cream will resume.

http://www.spearpharma.com

Stephen Basile

Senior Vice President, Sales and Marketing

Spear Pharmaceuticals, Inc.

973-895-6447 phone

basile@spearpharma.com


'/>"/>
SOURCE Spear Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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:8/18/2017)... ... August 18, 2017 , ... More than 20,000 pairs of ... Congo (DRC) thanks to an ambitious venture that conjoined the passions of an NBA ... support of the Liberty community. These shoes will save lives from the rampant infections ...
(Date:8/18/2017)... ... August 18, 2017 , ... Mediaplanet today announces the launch ... lifestyles and highlighting the importance of proactive eye and ear health. The campaign ... latest innovations in hearing aid technology. , In this issue, the National ...
(Date:8/18/2017)... , ... August 18, 2017 , ... ... handling handheld devices. Through an educational webinar, they will present the line of ... chance to learn how easy you can automate everyday pipetting tasks. , Ideal ...
(Date:8/18/2017)... ... 2017 , ... Radabaugh & Associates, a family managed agency ... West Virginia, is embarking on a cooperative charity effort with the Chestnut Mountain ... Chestnut Mountain Ranch (CMR) is a Christ-centered boarding school for young men offering ...
(Date:8/18/2017)... ... August 18, 2017 , ... The Brian Gifford Agency, an ... is campaigning in support of Campagna Academy in a charity drive to provide for ... Boys’ Town of Indiana,” Campagna Academy is a nonprofit organization that has offered critical ...
Breaking Medicine News(10 mins):
(Date:8/15/2017)... AccuGenomics, Inc., a diagnostic company based in ... the company has provided an AccuKit to the HIV ... Chapel Hill and to Qura Therapeutics for evaluation in ... HIV reservoir and viral expression in human CD4+ T ... Center is a joint initiative between the University of ...
(Date:8/8/2017)... Aug. 8, 2017  BioLineRx Ltd. (NASDAQ/TASE: BLRX), a ... reports its financial results for the second quarter ended ... the second quarter 2017 and to date: ... development programs for the Company,s lead project, BL-8040: ... study with BL-8040 as novel stem cell mobilization treatment ...
(Date:8/7/2017)... 2017  Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation,s largest ... June 30, 2017.  All comparisons, unless otherwise noted, are to ... Second Quarter 2017 Highlights include: ... an increase of 3.5% Total prescriptions dispensed ... of 7.5% versus 7.6% Gross profit ...
Breaking Medicine Technology: