Generic Version

Type: Keyphrase
Name: Generic Version
First reported 21 hours ago - Updated 1 hour ago - 2 reports

Judge Grants Temporary Stay On Sale Of Generic's Of Hospira's Precedex

Pharmaceutical and medication delivery company Hospira, Inc. (HSP: Quote) revealed in a regulatory filing on Wednesday that a federal judge has granted a temporary restraining order against the U.S. Food and Drug Administration or FDA's, decision to allow ... [Published RTTNews.com - 14 hours ago]
First reported 2 hours ago - Updated 2 hours ago - 1 reports

10 cheapest 'buy'-rated stocks as S&P 500 hits a high

It proves that, despite talk of an overheated market, there are still bargains to be had. The stock market's been holding up nicely this summer -- and the S&P 500 Index reached an all-time high today -- as investors have put aside worries about overvalued ... [Published Morningstar.com - 2 hours ago]
Entities: S&P 500, Stocks, Copaxone
First reported 18 hours ago - Updated 18 hours ago - 1 reports

Mylan Launches Generic Xeloda® Tablets

By a News Reporter-Staff News Editor at Pharma Business Week -- Mylan Inc. (Nasdaq: MYL) announced that it has launched Capecitabine Tablets USP, 150 mg and 500 mg, the generic version of Genentech's Xeloda® Tablets. Mylan received final approval from ... [Published 4 Traders - 18 hours ago]
First reported Aug 20 2014 - Updated Aug 20 2014 - 1 reports

Obamacare and the Aims of Progressivism

Consumer Power Report #433 the provision of health care, historically, has been an arena populated in America by a host of civil society institutions. These institutions were purposefully displaced by government over the course of the past century:These ... [Published Heartlander Magazine - Aug 20 2014]
First reported Aug 19 2014 - Updated Aug 20 2014 - 1 reports

Mylan launches generic version of Precedex

16:12 ET | About: Mylan Inc (MYL)After the FDA approved its ANDA yesterday, Mylan (MYL +1.3%) launches dexmedetomidine hydrochoride injection, 100 mcg (base)/mL, the therapeutic equivalent of Hospira's (HSP -2.8%) Precedex. The U.S. market is ~$156M ... [Published Seeking Alpha - Aug 19 2014]
First reported Aug 20 2014 - Updated Aug 20 2014 - 1 reports

Mylan launches generic version of Precedex injection

Mylan has launched its new dexmedetomidine hydrochoride injection, 100 mcg (base)/mL after receiving the final approval from the US Food and Drug Administration (FDA) for the product’s Abbreviated New Drug Application (ANDA). ... [Published PBR - News - Aug 20 2014]
First reported Aug 19 2014 - Updated Aug 20 2014 - 1 reports

Indian Health Ministry seeking compulsory license for B-MS’ Sprycel

Anti leukemia drug dasatinib, made by US pharma major Bristol-Myers Squibb (NYSE: BMY) and sold in India under the brand name Sprycel, could be in the dock once again, with the Health Ministry requesting anew the grant of a compulsory license for the ... [Published Pharma Letter - Aug 19 2014]
First reported Aug 19 2014 - Updated Aug 19 2014 - 1 reports

Alabama Supreme Court Reaffirms That Plaintiffs Who Use Generic Drugs Can Recover From Brand-Name Manufacturers

, the Alabama Supreme Court held for the second time in Wyeth v. Weeks , No. 1101397 (Ala. 2014) that a plaintiff who took only the generic version of the heartburn medication Reglan could nevertheless proceed against the manufacturers of the brand-name ... [Published Baker & Daniels - Aug 19 2014]
First reported Aug 19 2014 - Updated Aug 19 2014 - 1 reports

Pharma Patent Ruling Pinches Opportunities in Emerging Markets

The decision by an Indian court not to grant a new patent to drug firm Novartis for a modified form of its cancer drug Glivec (known as Gleevec in the U.S.) was a heavy blow to the company. It may be more than that, though, as other pharmaceutical companies ... [Published AdvisorOne - Aug 19 2014]
First reported Aug 18 2014 - Updated Aug 18 2014 - 1 reports

Court Report - August 2014 #3

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases .Unimed Pharmaceuticals LLC et al. v. Perrigo Co. et al.1:14-cv-01004; filed July 31, 2014 in the District Court of Delaware• Plaintiffs:  Unimed Pharmaceuticals ... [Published JD Supra - Aug 18 2014]
First reported Aug 18 2014 - Updated Aug 18 2014 - 1 reports

Feds To Withhold Some Doctor Payment Data After Inconsistencies

The Centers For Medicare & Medicaid Services said Friday that a third of the records in a database showing drug and device-maker contributions to doctors will be withheld next month when the website goes live because of data inconsistencies.ProPublica ... [Published Kaiser Health News - Aug 18 2014]
First reported Aug 18 2014 - Updated Aug 18 2014 - 1 reports

First Edition: August 18, 2014

Patients who rely on pacemakers and defibrillators run risk of serious health complicationsAAWC partners with EWMA and AWMA to develop unprecedented guidance documentITS develops new T cell vaccine to protect humans from seasonal and pandemic influenza ... [Published News-Medical.Net - Aug 18 2014]

Quotes

This may remind you of "Dr. Strangelove, Or: How I Learned to Stop Worrying and Love the Bomb" the Stanley Kubrick film from 1964...
...pecifically these Phase 2a data in the cellulite indication," said Adrian Adams , Chief Executive Officer and President of Auxilium Pharmaceuticals. "We believe these data establish proof-of-concept for CCH as a potential treatment for cellulite and enable Auxilium to pursue our development and regulatory strategy to most efficiently and effectively advance this exciting program. We look forward to initiating a planned Phase 2b clinical trial in the second quarter of 2015."
CEO Heather Bresch commented, "The approval of this product, one of a number of key approvals that had been pending with FDA , adds an important product to our broad and growing oncology franchise. We look forward to bringing a lower cost generic version of this product to patients."
...With this ruling, Depomed's market exclusivity will be protected until 2024. In a statement from the company, CEO Jim Schoeneck said the ruling "confirms the innovation of Gralise and the strength of our patents."

More Content

All (561) | News (405) | Reports (0) | Blogs (149) | Audio/Video (0) | Fact Sheets (0) | Press Releases (6)
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10 cheapest 'buy'-rated stocks as S&P 500 hits ... [Published Morningstar.com - 2 hours ago]
Tata Motors, Tupperware Brands, Hospira, Mylan ... [Published Yahoo! Finance - 6 hours ago]
Auxilium Pharmaceuticals, Inc. Announces Positi... [Published Securities Technology Monitor - 6 hours ago]
Judge Grants Temporary Stay On Sale Of Generic'... [Published RTTNews.com - 14 hours ago]
Mylan Launches Generic Xeloda® Tablets [Published 4 Traders - 18 hours ago]
Security, economic fears push Lebanese into dep... [Published Lebanon Daily Star - 20 hours ago]
Hospira Sues FDA on Generic Precedex Approval, ... [Published Yahoo! Finance - 21 hours ago]
Google, the House of Lords and the timing of th... [Published JD Supra - 22 hours ago]
Rand Paul Has a Moment, Millennials Shrug [Published Bloomberg View - Aug 20 2014]
Obamacare and the Aims of Progressivism [Published Heartlander Magazine - Aug 20 2014]
Court Finds Patent Invalid; Then Orders Defenda... [Published Patent Law Blog (Patently-O) - Aug 20 2014]
In Generic PRECEDEX Litigiation, Hospira Wins T... [Published FDA Law Blog - Aug 20 2014]
Depomed scores a win in its epic struggle to fe... [Published FiercePharma - Aug 20 2014]
Hospira Taking FDA To Court [Published Bidness Etc - Aug 20 2014]
Mylan launches generic version of Precedex inje... [Published PBR - News - Aug 20 2014]
GRANTING CL FOR DASATINIB [Published PharmaBiz - Aug 20 2014]
Alabama Supreme Court Reaffirms That Plaintiffs... [Published Baker & Daniels - Aug 19 2014]
3 Reasons Mylan Inc Stock Could Rise [Published Motley Fool - Aug 19 2014]
Heninger Garrison Davis Clients To Get Their Da... [Published Reuters - Aug 19 2014]
Dow Flirts With 19,000, S&P 500 Approaches 2,00... [Published Benzinga.com - Aug 19 2014]
Mylan launches generic version of Precedex [Published Seeking Alpha - Aug 19 2014]
Mylan Launches Generic Precedex Sedative as Hos... [Published Pharmacy Times - Aug 19 2014]
Healthcare Review: Depomed, Oncothyreon, Amgen,... [Published BioMedReports - Aug 19 2014]
FDA approves Mylan’s Precedex generic [Published Drug Store News - Aug 19 2014]
Why DepoMed (DEPO) Stock Is Gaining Toda [Published The Street Latest - Aug 19 2014]
Depomed prevails over Actavis in Gralise patent... [Published Seeking Alpha - Aug 19 2014]
Eli Lilly Gets Tentative FDA Approval For Diabe... [Published Bidness Etc - Aug 19 2014]
Indian Health Ministry seeking compulsory licen... [Published Pharma Letter - Aug 19 2014]
Fuhgeddaboudit: FDA Takes a Different Road on G... [Published FDA Law Blog - Aug 19 2014]
Pharma Patent Ruling Pinches Opportunities in E... [Published AdvisorOne - Aug 19 2014]
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Blogs

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Court Finds Patent Invalid; Then Orders Defenda... [Published Patent Law Blog (Patently-O) - Aug 20 2014]
By Dennis Crouch Following the Supreme Court’s equitable relief decision in eBay, many patentees have found it difficult to obtain injunctive relief to stop ongoing infringement – even after final judgment that the patent is both valid and infringed. ...
In Generic PRECEDEX Litigiation, Hospira Wins T... [Published FDA Law Blog - Aug 20 2014]
By Kurt R. Karst –The pace of litigation concerning FDA’s approval of generic versions of Hospira, Inc.’s (“Hospira’s”) PRECEDEX (dexmedetomidine HCl) Injection, 100 mcg (base)/mL packaged in 200 mcg(base)/2 mL single-dose vials, has been anything but ...
Mylan launches generic version of Precedex inje... [Published PBR - News - Aug 20 2014]
Mylan has launched its new dexmedetomidine hydrochoride injection, 100 mcg (base)/mL after receiving the final approval from the US Food and Drug Administration (FDA) for the product’s Abbreviated New Drug Application (ANDA). ...
Fuhgeddaboudit: FDA Takes a Different Road on G... [Published FDA Law Blog - Aug 19 2014]
By Kurt R. Karst –We were beginning to wonder whether FDA would ever issue a letter decision addressing the novel issues raised in the Agency’s January 15, 2014 “Dear NDA/ANDA Applicant” letter (Docket No. FDA-2014-N-0087) concerning approval of generic ...
Sanofi launches generic version of Eloxatin [Published PBR - News - Aug 13 2014]
Sanofi US, through its generics division Winthrop US, has launched an authorized generic version of Eloxatin (oxaliplatin injection). ...
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Press Releases

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Mylan Wins Motion to Enjoin GlaxoSmithKline fro... [Published Financial Services - Jul 17 2014]
Milan District Court Confirms the Validity of A... [Published Financial Services - Jun 12 2014]
ACETO Subsidiary Rising Pharmaceuticals Launche... [Published GlobeNewswire: Acquisitions News - Jun 11 2014]
CorePharma, LLC Announces the Launch of Dextroa... [Published Financial Services - Jun 04 2014]
ACETO Subsidiary, Rising Pharmaceuticals, Has L... [Published GlobeNewswire: Acquisitions News - May 27 2014]
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