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 The leading web portal for pharmacy resources, news, education and careers January 31, 2015
Pharmacy Choice - News - Generic Drugs - January 31, 2015

Pharmacy News

 Generic Drugs
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1/30/15 - ANI Pharmaceuticals Announces the Launch of Etodolac 300mg Capsules
The US market for Etodolac 300 mg capsules totals $9 million on a trailing 12 month basis, per IMS Health. Arthur S. Przybyl, President and Chief Executive Officer said, "We are pleased to announce the launch of our second product from the portfolio of approved generic products we acquired from Teva in January 2014." ANI Pharmaceuticals, Inc. is an
1/30/15 - FDAnews New Management Report: Expediting the FDA Generic Drug Approval Process
The FDA continues to struggle to catch up on ANDA approvals. Discover the three biggest areas of application deficiencies that trigger RTR decisions bioequivalence; chemistry, manufacturing and controls (CMC) quality; and organization and formatting and learn which problems trigger FDA alarm-bells. Plus, see how to avoid other areas that can le
1/30/15 - FTC clears Sun Pharma's $4B purchase of competitor Ranbaxy
NEW YORK Sun Pharmaceuticals will sell the rights to one generic drug as part of its purchase of competitor Ranbaxy Laboratories, U.S. antitrust regulators said Friday. The Federal Trade Commission said the companies will sell Ranbaxy's interests in generic minocycline, an antibiotic used to treat several types of infections. Torrent Pharmaceuti
1/30/15 - Ireland : ACTAVIS PHARMACEUTICALS buys AUDEN MCKENZIE for 306m, following major acquisitions [TendersInfo (India)]
Ireland- based Actavis Pharmaceuticals has acquired generic drug maker Auden Mckenzie in a deal worth 306 m. Before it announced the Allergan deal in November, the company acquired rival Forest Laboratories for $25 bn in February and infectious disease expert Durata for $675 m in October. Actavis said the acquisition of Auden Mckenzie will make i
1/29/15 - Absorption Systems and Provenir Scientists Address the Challenges of Developing Generic Complex Drug Products [Global Data Point]
AAPS is the American Association of Pharmaceutical Scientists.&# x0D;. This meant that large, expensive trials with clinical endpoints were required; the U.S. Food and Drug Administration has acknowledged that this is the least accurate, sensitive, and reproducible approach for demonstrating equivalence.&# x0D;. In order to promote the development
1/29/15 - BIOCAD - World Leader in Biosimilar Rituximab Sales
Company revenue from sales of Acellbia?, exceeded $155 million in 2014, representing more than 80% of global sales of non-originator rituximab biologicals. Most of BIOCAD's rituximab sales were in Russia, where the company won a series of federal government contracts to supply programs that provide high-value, life-saving drugs to patients for wh
1/29/15 - DCGI to renew focus on NE states to assess drug quality and GMP standards [Forexpros]
The sampling exercise started by Drug Controller General of India in States like Jammu and Kashmir, Himachal Pradesh, Maharashtra, Tamil Nadu, Maharashtra, Rajasthan and Chhatisgarh last year will now also be taken up in North Eastern states to assess the quality of drugs in the coming months. Against the backdrop of the fact that several drug manu
1/29/15 - Ranbaxy earnings pulled back down by manufacturing issues [EMBIN (Emerging Markets Business Information News]
Last year Ranbaxy Laboratories managed to report a one-quarter profit by getting the FDA to allow it to launch its exclusive of generic Diovan from its plant in New Jersey. Ranbaxy had a first-to-file exclusive on the drug but was in the midst of dealing with FDA quality concerns when it went off patent in September 2012. The FDA worked with the co
1/29/15 - Ranbaxy forfeits 180 days exclusivity for generic Nexium [India Business] [Times of India]
NEW DELHI: Ranbaxy Laboratories has lost the opportunity to exclusively market in the United States for six months the first generic version of Anglo Swedish drug innovator Astra Zeneca's heartburn drug Nexium, the Delhi- based company said in a filing to the stock exchange on Tuesday. The company, which is in the process of getting acquired by riv
1/28/15 - 'Expensive' placebo drug proves more effective than 'cheap' placebo
For the most part, there is no difference chemical or otherwise between generic drugs and their more expensive, brand-name counterparts. "Patients' expectations play an important role in the effectiveness of their treatments, and the placebo effect has been well documented, especially in people with Parkinson's disease," explained lead study a
1/28/15 - 5th Appel Biosimilars Conference 2015
WHEN: Tuesday 3rd of March 2015- Thursday 5th of March 2015. WHERE: Novotel London Greenwich Hotel 173-185, Greenwich High Rd, London, SE10 8 JA. According to market research report,' PharmaSphere: Global Biosimilars Strategy- Regulatory Landscape, Key Drivers, Markets and Trends in 2013' published by GlobalData, the global biosimilars market is ex
1/28/15 - Absorption Systems and Provenir Scientists Address the Challenges of Developing Generic Complex Drug Products
AAPS is the American Association of Pharmaceutical Scientists. This meant that large, expensive trials with clinical endpoints were required; the U.S. Food and Drug Administration has acknowledged that this is the least accurate, sensitive, and reproducible approach for demonstrating equivalence. In order to promote the development of generic versi
1/28/15 - Actavis to buy Auden Mckenzie for GBP306m [EMBIN (Emerging Markets Business Information News]
Actavis, a leading global specialty pharmaceutical company, and the owners of Auden Mckenzie Holdings Limited, a dynamic and fast growing company focused on the development, licensing and marketing of niche generic medicines and proprietary brands in the UK, announced that they have reached a definitive agreement, under which Actavis will acquire A
1/28/15 - Promote Indian drugs, US health groups urge Obama [India Business] [Times of India]
NEW DELHI: Leading US health groups including AVAC, Oxfam America, amfAR, Health Global Access Project, TAG and others have written to Barack Obama urging him to support India in providing "high-quality, low-cost generic medicines essential for health care around the world". There are concerns that US is pressuring India to push for liberal policie
Ranbaxy Laboratories has lost the 180- day exclusivity period for launching its generic version of the heartburn drug Nexium 20 milligrams and 40 mg capsules in US. The sales would have added $170 million to Ranbaxy's revenue. The US Food and Drug Administration has permitted Teva Pharmaceuticals of Israel to launch its generic version of Nexium.
1/28/15 - Ranbaxy loses US generic exclusivity over $6 bn Nexium [DNA : Daily News & Analysis (India)]
In a filing on BSE, Ranbaxy said, "We have now received a communication from US FDA that they have determined that Ranbaxy has forfeited its 180- day exclusivity for esomeprazole magnesium delayed release capsule 20 mg and 40 mg." While Ranbaxy said it is disappointed with the result and is pursuing all available legal options to preserve its right
1/28/15 - Uphold spirit of Medicines Policy [New Straits Time (Malaysia)]
In support of the concept of Essential Medicines, a model list of essential drugs, which included about 200 generic drugs and vaccines, was prepared by the World Health Organisation in 1977.. Most WHO member states welcomed the new approach to medicines and Malaysia is no exception. The concept of essential medicines had been adopted in Malaysia's
1/27/15 - Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792
Under the Paperwork Reduction Act of 1995, Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. Submit written comments on the collectio
1/27/15 - BRIEF: FDA approves Teva's generic AstraZeneca heartburn drug [Globes, Tel Aviv, Israel]
Jan. 27 Teva Pharmaceutical Industries Ltd. has announced that it has received Food and Drug Administration approval for the first generic equivalent to Nexium Delayed-Release Capsules in the United States. Teva says that it is preparing to launch the product in the near future. Nexium Delayed-Release Capsules, marketed by AstraZeneca, had annual
1/27/15 - FDA approves first generic esomeprazole
Release date- 26012015- The U.S. Food and Drug Administration today approved the first generic version of Nexium to treat gastroesophageal reflux disease in adults and children ages 1 and older. Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 milligram capsules.
1/27/15 - Fitch: SCOTUS Extends Patent Benefit for Teva; Generics Lose for Now [Professional Services Close - Up]
Notably, the U.S. Food and Drug Administration has not yet approved any submitted generic versions, even though market exclusivity under the original appeals court ruling expired in May 2014. In the meantime, Teva can keep working to convert patients to its less frequently administered 40 mg formulation. Teva exceeded initial expectations in 2014 a
1/27/15 - Global Generic Drugs Market Industry Trends and Forecasts Up to 2018
Transparency Market Research includes new market research report "Generic Drugs Market" to its huge collection of research reports.Albany, NY 01/27/2015 The generic drugs industry comprises of the manufacture and marketing of certain drugs which have the same active ingredients as the brand-name drugs manufactured by any pharmaceutical compan
1/27/15 - Japanese Biosimilar Market Performance Discussed by MP Advisors in New Research Report Available at
Furthermore, the biosimilars' adoption is much faster in Japan than, for example, in the US, primarily owing to the less stringent regulations on market-entry in Japan. The current year is regarded as a litmus test for overall JPY 400 billion biosimilar opportunity in the country through the 5 upcoming years as well as will likely shed light on the
1/27/15 - Novartis Q4 Profit Declines, Expects Growth In FY15
BASEL- Swiss pharmaceutical giant Novartis AG reported Tuesday lower profit in its fourth quarter, mainly reflecting the impact of its divestments as it aims to focus on core businesses of innovative pharmaceuticals, eye care, and generics. Further, Novartis said its Board proposed a dividend payment of 2.60 Swiss francs for 2014, up 6 percent from
1/27/15 - Perrigo Company plc Announces Quarterly Dividend
From its beginnings as a packager of generic home remedies in 1887, Perrigo Company plc, headquartered in Ireland, has grown to become a leading global healthcare supplier. Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, nutritional products and active pharmaceutical ingredients, and...
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