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 The leading web portal for pharmacy resources, news, education and careers August 3, 2015
Pharmacy Choice - News - Generic Drugs - August 3, 2015

Pharmacy News

 Generic Drugs
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 250     Next >>     Go To Page:

8/3/15 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2016
The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Generic Drug User Fee Amendments of 2013, authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/o
8/3/15 - Biosimilar User Fee Rates for Fiscal Year 2016
SUMMARY: The Food and Drug Administration is announcing the rates for biosimilar user fees for fiscal year 2016. The Federal Food, Drug, and Cosmetic Act, as amended by the Biosimilar User Fee Act of 2012, authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain appl
8/3/15 - Generic Drug User FeeAbbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active...
SUMMARY: The Food and Drug Administration is announcing the rates for abbreviated new drug applications, prior approval supplements to an approved ANDA, drug master files, generic drug active pharmaceutical ingredient facilities, and finished dosage form facilities user fees related to the Generic Drug User Fee Program for fiscal year 2016. The Fed
8/3/15 - MarketsandMarkets: Biosimilars Market worth $6.22 Billion by 2020
The global biosimilars market is expected to reach $6.22 Billion by 2020 from $2.29 Billion in 2015, at a CAGR of 22.1% from 2015 to 2020.. Geographically, the global biosimilars market is dominated by Europe, followed by Asia-Pacific, Rest of the World, and North America. The key players in the global biosimilars market include Sandoz Internationa
8/3/15 - QUACK MOLD DOCTOR AND CHOLESTYRAMINE BLAMED IN THE DEATH OF A 64 YEAR OLD OHIO MAN
Bandwagon mold doctors using Cholestyramine are now the targets of Composite Medical Boards across the nation. A newbie Ohio mold doctor, who refused comment; is now being blamed for the death of a 64 year old Ohio man using a cholesterol medication "Cholestyramine" in an attempt to try and detoxify the patient from mold exposure. A drug which no s
8/2/15 - FDA Issues Notice on Animal Generic Drug User Fee Rates
A Notice by the Food and Drug Administration on 08/03/2015. The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Generic Drug User Fee Amendments of 2013, authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such
8/2/15 - FDA Issues Notice on Biosimilar User Fee Rates
Dates: No later than 5 calendar days after FDA grants the sponsor's request for a BPD meeting for that product or upon the date of submission of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application. The Food and Drug Administration is announcing the rates for biosimilar user fees
8/2/15 - FDA Issues Notice on Generic Drug User Fee-Abbreviated Application
WASHINGTON, Aug. 2 The Department of Health& Human Services published the following notice in the Federal Register from the Food& Drug Administration:. The Food and Drug Administration is announcing the rates for abbreviated new drug applications, prior approval supplements to an approved ANDA, drug master files, generic drug active pharmaceutica
8/2/15 - Mylan One of First to Launch Generic Version of Namenda Tablets
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Mylan N.V. announced the U.S. launch of Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, which is the generic version of Forest's Namenda Tablets. Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, had U.S. sales of approximately $1.4 billion for the 12 months ending Mar
8/1/15 - BRIEF: Trib 30 index slips in July; 29 percent drop makes ATI biggest loser [The Pittsburgh Tribune-Review]
Generic drugmaker Mylan NV dropped 18 percent since Teva Pharmaceutical Industries dropped an unsolicited bid for the company. Nine companies American Eagle Outfitters, Ansys, Bank of New York Mellon, Comcast, First Commonwealth, FNB Corp., Matthews International, PNC Financial and Thermo Fisher Scientific logged 52- week highs during the month
8/1/15 - United States : US FDA approves Sofgen's Nimodipine 30mg capsule [TendersInfo (India)]
ANI Pharmaceuticals, Inc. disclosed that its ANDA collaboration partner Sofgen has obtained approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Nimodipine 30 mg capsules. According to IMS Health, trailing twelve-month sales for the product are $25 million with two current competitors. Arthur S. Przybyl, pr
8/1/15 - UPDATE2: Pacific Rim nations short of final free trade deal: sources
In Hawaii, the 12 countries remained at odds over patent periods for next-generation medicines, with the United States calling for around 10 years to benefit pharmaceutical companies and Australia proposing five years to encourage generic drug production. New Zealand's demand for greater access to dairy markets in countries such as Canada and Japan
7/31/15 - Astrazeneca's revenue better than forecast
ASTRAZENECA revenue fell by a smaller-than-expected seven per cent in the second quarter, as income from selling rights to medicines offset generic competition to older drugs and a strong dollar. The drugmaker increased its revenue forecast for the year and said it now expected a low single-digit percentage decline, against mid single-digit previou
7/31/15 - Hospira Announces U.S. Launch of Generic Bivalirudin for Injection
By a News Reporter-Staff News Editor at Health& Medicine Week Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, announced it had obtained U.S. Food and Drug Administration approval for the launch of bivalirudin for injection, a generic version of The Medicines Company's
7/31/15 - In vivo study of generic drug products in human subjects [TendersInfo (India)]
Solicitation: In vivo study of generic drug products in human subjects Response Date: Aug 13, 2015 Archiving Policy: Automatic, on specified date Archive Date: August 14, 2015 Major organization: DEPARTMENT OF HEALTH AND HUMAN SERVICES Address: 5630 Fishers Lane Room 2129 Rockville Maryland 20857-0001 Primary Point of Contact: Linda Troutman, Contr
7/31/15 - Investigators from Chugai Pharmaceutical Target Colony-Stimulating Factors (Effective use of modeling and simulation in designing bioequivalence and...
According to news reporting originating from Tokyo, Japan, by NewsRx correspondents, research stated, "Bioequivalence and comparability studies are necessary for changing formulations of large-molecule drugs, such as antibody drugs and protein products, and in the development of their biosimilars. For more information on this research see: Effectiv
7/31/15 - Israel,United States : TEVA PHARMACEUTICAL seeks to take over Allergan`s generics unit [TendersInfo (India)]
Teva Pharmaceutical Industries Ltd is planning to purchase Allergan PLC s generics unit for $40.5 billion. Allergan would be paid with $33.75 billion in cash from Teva and with shares worth around $6.75 billion, which would make up for about 10% of the company s possession. DealBook s Chad Bray says, The Allergan deal cements Teva s position as the
7/31/15 - Jordan : HIKMA PHARMACEUTICALS to acquire generic drug maker for $2.65B [TendersInfo (India)]
The deal will see Hikma paying $1.18 billion in cash and issue 40 million new Hikma shares, or 16.71% of its expanded stock capital, to the German seller. Hikma based the valuation on an agreed stock price of 2,350 pence per Hikma stock, a 13% premium over Monday's London close, and an exchange rate of $1.56 to the British pound. For Hikma, the acq
7/31/15 - Middle Eastern Business Headlines At 6:12 a.m. GMT
Explosion shuts down Iran-Turkey natural gas pipeline UAE slashes fuel subsidies, announces 24 percent price hike Dubai launches expansion of Mideast's biggest port Cyprus, Israel seek to bolster energy, security cooperation Israel's Teva buys Allergan generic drug company for $40.5 B Russia to upgrade air defense missiles intended for Iran Austral
7/31/15 - Middle Eastern Business Headlines At 6:44 a.m. GMT
Explosion shuts down Iran-Turkey natural gas pipeline UAE slashes fuel subsidies, announces 24 percent price hike Dubai launches expansion of Mideast's biggest port Cyprus, Israel seek to bolster energy, security cooperation Israel's Teva buys Allergan generic drug company for $40.5 B Russia to upgrade air defense missiles intended for Iran Austral
7/31/15 - Pharmaceutical products [TendersInfo (India)]
Contract award: purchase with the delivery of drugs overall, preparations for anesthesia and premedication, oncology, drugs affecting bone mineralization, buffered formalin, hemostatic dressings for hospital pharmacies holy cross cancer center in kielce. The contract is for the purchase and the supply of generic drugs, preparations for anesthesia a
7/31/15 - Romark Laboratories and Lupin Pharmaceuticals Respond to Recent Cryptosporidium (Crypto) Outbreak in Dallas [Manufacturing Close - Up]
According to a media release, Romark Laboratories is a Tampa- based pharmaceutical company committed to the discovery, development and commercialization of innovative small molecules for treating infectious diseases, and Lupin Pharmaceuticals is the 6th largest pharmaceutical company in the U.S. with a wide portfolio of generic and branded medicine
7/31/15 - Teva Secures $33.75 Billion Financing Commitment
Teva Pharmaceutical Industries Ltd. today announced that it has entered into commitment letters relating to its pending acquisition of Allergan s generic pharmaceuticals business with Bank of America Merrill Lynch, Barclays Bank PLC, BNP Paribas, Citi, Credit Suisse, HSBC, Mizuho Bank, Morgan Stanley Senior Funding, Inc., RBC Capital Markets and
7/31/15 - United States : HIKMA PHARMACEUTICALS buys U.S. Generic Pharmaceutical Business [TendersInfo (India)]
The organization would buy 100% stock in Roxane Labs Inc., which is the collective name for Boehringer s generic pharmaceutical business, Roxanne Laboratories Inc., and its manufacturing supply chain affiliate, Boehringer Ingelheim Roxane Inc.. The $2.65 billion valuation comes from up-front payments, plus milestones and royalties related to certai
7/30/15 - Allergan Confirms Generic Tyvaso Patent Challenge
WASHINGTON- Allergan Plc. confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration, seeking approval to market Treprostinil Inhalation Solution, 0.6 mg/mL, 2.9 mL ampules. Allergan's ANDA product is a generic version of United Therapeutics Corporation's Tyvaso, which is indicated for the treatment o
Articles(s): 1 - 25 of 250     Next >>     Go To Page:


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