22.10.2011
Generics in the United Kingdom - Performance of the Market Is Forecast To Decelerate, With an Anticipated CAGR Of 7.9% for the Five-Year Period 2010... [reading]

22.10.2011
The US Generics Market Had Total Revenue of $71.4 Billion in 2010, Representing A CAGR Of 8.2% between 2006 and 2010 [reading]

21.10.2011
Antares Pharma Granted New U.S. Patent Covering VIBEX? Injector Technology [reading]

21.10.2011
Drugs giants probed by EU anti-trust authority [Deutsche Welle] [reading]

20.10.2011
CMS` Transparency Push Could Revolutionize Drug Pricing [reading]

19.10.2011
Perrigo confirms filing for generic version of PATANASE nasal spray [reading]

19.10.2011
Pharmacists to Federal Medicaid Officials: Revamp Proposed Generic Drug Federal Upper Limits to Preserve Pharmacy Access for Patients [reading]

19.10.2011
Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent Orders To Aid Public Comment [reading]

18.10.2011
Perrigo applies to FDA for generic nasal spray [reading]

18.10.2011
Watson confirms filing ANDA for generic version of Warner`s Atelvia [reading]

18.10.2011
Watson confirms filing ANDA with FDA for generic version of Noven`s Daytrana [reading]

17.10.2011
New NCPA Ads Feature Community Pharmacy Proposals to Reduce the Federal Deficit [reading]

Generic drugs news

Apicore files drug master file with FDA for anticoagulant drug

Jul 08, 2010 (Datamonitor via COMTEX) Apicore, a developer of specialty active pharmaceutical ingredients, has filed a drug master file for fondaparinux sodium active pharmaceutical ingredient, or API, with the FDA.

According to Apicore, since 2007, the company has partnered with a major generic pharmaceutical company to develop the API and prefilled syringes with the goal of obtaining approval for an abbreviated new drug application (ANDA) to distribute a generic product equivalent to the brand name product Arixtra.

Completion of the development, scale-up and validation of the company`s manufacturing process and testing procedures for the API represents a significant milestone for Apicore and its partner on the path toward commercialization of a generic version of Arixtra, the company said.

Ambrose Stafford, vice president of Apicore, said: "We`re very proud of the skill and dedication of our team who have worked tirelessly over several years to achieve this major milestone of completing the development of fondaparinux sodium API. With the same dedication and focus we look forward to continuing to work with our partner to complete the process of obtaining ANDA approval to distribute a generic version of Arixtra pre-filled syringes, for which no generic option exists today."

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What's the difference between generic drugs and brand-name drugs?
Actually, they both differ only in price and name, all the rest is the same. Generic drugs, as well as brand-name medications, have the same dosage, effects, including side effects, risks, strength and safety. They are like true copies of brand-name medications.

What makes generic drugs cheaper?
As a rule, in order to release and patent a certain drug the manufacturer should meet a range of requirements like developing, researching, marketing and promoting of a new medication. Overall, it is time- and money-consuming procedure, which leads to price growth. Speaking about generic drugs, they are usually brought unregistered onto the market, thus the manufacturer is exempt from paying taxes. However, the lower price here doesn't yield lower effectiveness. As a rule, the manufacturers of generic drugs are known reputable pharmaceutical companies.

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