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 The leading web portal for pharmacy resources, news, education and careers October 31, 2014
Pharmacy Choice - News - Generic Drugs - October 31, 2014

Pharmacy News

 Generic Drugs
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 47     Next >>     Go To Page:

10/31/14 - Determination That TOPICORT (Desoximetasone) Cream and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. The 1984 amendments include what is now section 505 of
10/31/14 - Dr. Reddy's Debuts Sirolimus Tablets [Health & Beauty Close - Up]
Dr. Reddy's Laboratories reported that it has launched Sirolimus Tablets 1 mg and 2 mg, a therapeutic equivalent generic version of Rapamune tablets in the US market on October 27, following the approval by the United States Food& Drug Administration. According to a company release, Sirolimus tablets in 1 mg and 2 mg are available in bottle counts
10/31/14 - Generic producers line up as Viagra patent expires [China Daily: Hong Kong Edition]
US pharmaceutical giant Pfizer sold some 300 million doses of Viagra worldwide by 2013. The company applied for the patent in China in 1994 and was granted 20- year exclusive rights in 2001.. There are about 140 million patients with erectile dysfunction in China, according to a report released by Guosen Securities in May. And though its exclusive
10/31/14 - Impax Announces R%7ED Reorganization Designed to Yield Process Improvements and Efficiencies [Global Data Point]
As a result of the reorganization, the generic R %7 ED organization will be responsible for early stage product development and analytical functions for all Impax products, while the brand R %7 ED organization will focus on phase II, III and IV clinical activities, drug safety and pharmacovigilance for all Impax products. This realignment of the R
10/31/14 - Teva raises 2014 profit forecast after strong third quarter [EMBIN (Emerging Markets Business Information News]
Teva, the world's largest generic drugmaker, raised its outlook for full-year earnings per share excluding one-time items to $5.00-$5.10 from a previous estimate of $4.90-$5.10, assuming there is no Copaxone competition this year. Analysts were estimating Teva would earn $4.97 a share. Chief Executive Erez Vigodman said Teva was optimistic the U.S.
10/31/14 - TPI Receives 'Innovation of the Year Award'
By a News Reporter-Staff News Editor at Drug Week Therapeutic Proteins International, LLC, a US based biosimilars company, received the' Innovation of the Year' award sponsored by Honeywell at the Global Generics and Biosimilars Awards held in Paris on Oct. 7, 2014. The three finalists for the' Innovation of the Year' award were Teva, Sandoz and
10/30/14 - AmerisourceBergen Reports Fourth Quarter and Fiscal Year 2014 Results
AmerisourceBergen Corporation today reported that in its fiscal year 2014 fourth quarter ended September 30, 2014, adjusted diluted earnings per share from continuing operations increased 35.8 percent to $1.10. Revenue increased 29.1 percent to $31.6 billion in the quarter. We delivered exceptional performance in our September quarter, completin
10/30/14 - Atlantic Canadians to Save $560-Million Through Unprecedented Three-Year Pan-Canadian Agreement on Generic Prescription Medicines
-Atlantic Canadians will save an estimated $560- million through an unprecedented three-year agreement reached between Canada's provinces and territories and the generic pharmaceutical industry, Jim Keon, President of the Canadian Generic Pharmaceutical Association, said today. "This national framework provides enormous additional savings to the..
10/30/14 - Biopharmaceutical Research and Manufacturing Sector Oppose Drug Take Back Ordinance
The Biotechnology Industry Organization issued the following news release:. The following statement can be attributed to BayBio, the Biotechnology Industry Organization, the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association and the Consumer Healthcare Products Association:. Along with the FDA and DEA, the.
10/30/14 - Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices
Dublin- Research and Markets has announced the addition of the "Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices" report to their offering. In this report, biopharmaceutical manufacturer decision-makers share their perspectives on:. -Expected outsourcing of commercial biosimilar manufacturing- Comfort level with...
10/30/14 - CHPA -Biopharmaceutical Research and Manufacturing Sector Oppose Drug Take Back Ordinance
The following statement can be attributed to BayBio, the Biotechnology Industry Organization, the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association and the Consumer Healthcare Products Association:. However, there is no rationale for mandating new, costly and redundant disposal options when both the Food a
10/30/14 - DRUG WAR: NOVARTIS, CIPLA IN PATENT FIGHT
Drugmaker Cipla has asked the Government of India to revoke five patents that Swiss company Novartis holds on respiratory drug Onbrez and has launched its generic version of indacaterol at a fifth of the price. Cipla has asked the Department of Industrial Policy and Promotion, Government of India to cancel the patents on the ground that Novartis ha
10/30/14 - Facilitating global development of biosimilars; EMA to allow use of non-EEA authorised comparator in clinical studies
ENP Newswire- 30 October 2014. Release date- 29102014- The European Medicines Agency has published its revised overarching guideline on biosimilars. This document, together with a series of complementary guidelines that were subsequently developed by EMA, have led to the approval of 19 biosimilars in the European Union to date, including the first
10/30/14 - LAURUS LABS RAISES Rs550 CRORE FROM BLUEWATER
Laurus Labs Ltd has raised Rs500 crore from Bluewater for a minority stake. The company intends to use the funds to expand its manufacturing facility at Visakhapatnam. Laurus caters for a number of generic global pharmaceutical companies.
10/30/14 - Mylan Launches Generic Viramune XR
Mylan Inc. today announced the U.S. launch of its Nevirapine Extended-release tablets, 400 mg, which is the generic version of Boehringer Ingelheim's Viramune XR . Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is indicated for combination antiretroviral
10/30/14 - NCI -Columbia U researchers find that generic medications boost adherence to breast cancer therapy
This is especially important given the rapid increase of expensive oral cancer therapies,' said study leader Dawn L. Hershman, MD, MS, associate professor of medicine at the College of Physicians and Surgeons, and associate professor of epidemiology at the Mailman School of Public Health, Columbia University Medical Center. Dr. Hershman is also lea
10/30/14 - Next Launch of First Biosimilars Plant in Algeria
The first plant for the manufacturing of biosimilar medicines will be launched in 2016 in Algeria, by Jordanian laboratory El Kendi, said Wednesday in Algiers, CEO of the laboratory Farouk Aissam. "The laboratory El Kendi will launch in 2016 a biosimilars plant, the first one in Algeria which still doesn't manufacture this class of molecules," sai
10/30/14 - Research and Markets: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices
Research and Markets has announced the addition of the "Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices" report to their offering. In this report, biopharmaceutical manufacturer decision-makers share their perspectives on:. -Expected outsourcing of commercial biosimilar manufacturing.
10/30/14 - Teva Reports Third Quarter 2014 Results
Teva Pharmaceutical Industries Ltd. today reported results for the quarter ended September 30, 2014. We also remain fully committed to transform and simplify our operational network and make quality a competitive competency for us, stated Erez Vigodman, President& CEO of Teva. Erez Vigodman continued, We are well positioned to achieve our goa
10/30/14 - TWi Pharmaceuticals Receives US FDA Approval on Generic Donepezil Hydrochloride Tablets USP, 23 mg, its fifth ANDA from US FDA
TWi Pharmaceuticals, Inc. today announced that it has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.' s Aricept 23 mg. TWi Pharmaceuticals is preparing to launch the product in the US via its
10/29/14 - Amgen Outlines Strategy, Growth Objectives And Capital Allocation Plans [Global Data Point]
Robert A. Bradway, chairman and chief executive officer at Amgen, opened the meeting by affirming that the Company's strategy will continue to focus on discovery and development of innovative medicines to address serious illnesses, development of branded biosimilars, next-generation biomanufacturing of high quality biologics, developing improved...
10/29/14 - Facilitating Global Development of Biosimilars
The European Union's Medicines Agency issued the following news:. The European Medicines Agency has published its revised overarching guideline on biosimilars. This document, together with a series of complementary guidelines that were subsequently developed by EMA, have led to the approval of 19 biosimilars in the European Union to date, including
10/29/14 - Generic producers line up as Viagra patent expires [China Daily: Hong Kong Edition]
US pharmaceutical giant Pfizer sold some 300 million doses of Viagra worldwide by 2013. The company applied for the patent in China in 1994 and was granted 20- year exclusive rights in 2001.. There are about 140 million patients with erectile dysfunction in China, according to a report released by Guosen Securities in May. And though its exclusive
10/29/14 - Klobuchar, Grassley Urge Federal Trade Commission to Release Data on Pay-For-Delay Settlements
Senators Amy Klobuchar and Chuck Grassley today urged the Federal Trade Commission to release data on pay-for-delay settlements. In a letter to FTC Chairwoman Edith Ramirez, the senators requested the prompt release of the agency's annual report summarizing agreements where brand-name drug companies pay generic drug companies to delay marketing low
10/29/14 - Lannett Receives FDA Approval for Letrozole Tablets USP 2.5 mg
Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Letrozole Tablets USP, 2.5 mg, the therapeutic equivalent to the reference listed drug, Femara Tablets, 2.5 mg, of Novartis Pharmaceuticals Corporation. Letrozole Tablets USP, 2.5 mg, repre
Articles(s): 1 - 25 of 47     Next >>     Go To Page:


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