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The FDA has given specialty drugmaker Fougera approval to market its acne treatment sulfacetamide sodium topical suspension 10 percent strength, a generic version of Dermik’s Klaron. Read More
A U.S. appeals court has upheld a lower court’s ruling maintaining the 180-day marketing exclusivity period for generic drugmakers Ranbaxy Laboratories and Teva Pharmaceuticals to market their versions of Merck’s Zocor, a cholesterol treatment drug that generated nearly $4.5 billion in sales for the brand company last year.
Although a legal basis for similar biological medical products has been established in the European Union (EU), paving the way for follow-on versions of original biological medicines, or biosimilars, there will likely be few products approved by this route.
A U.S. appeals court has upheld a lower court’s ruling maintaining the 180-day marketing exclusivity period for generic drugmakers Ranbaxy Laboratories and Teva Pharmaceuticals to market their versions of Merck’s Zocor, a cholesterol treatment drug that generated nearly $4.5 billion in sales for the brand company last year.
Calling the impact of recent regulatory amendments to Canada’s drug patent rules “unnecessary and costly to taxpayers,” generic drug manufacturers led by the Canadian Generic Pharmaceutical Association (CGPA) are calling on a federal court to repeal modifications to federal regulations that provide brand name manufacturers with eight years of freedom from generic drug competition.
With the Democrats taking control of the Senate next year, the healthcare agenda will likely focus on increasing the availability of generics in the market, improved drug safety and the role of trade policy in protecting domestic pharmaceuticals, according to industry observers.
The FDA's Office of Generic Drugs (OGD) will hold discussions with industry "in the next few weeks or months" on the possibility of introducing user fees to speed the generic approval process, Gary Buehler, the office's director, disclosed at the 2006 Generic Pharmaceutical Association Fall Technical Conference Oct. 19.
The FDA’s Office of Generic Drugs (OGD) will hold discussions with industry “in the next few weeks or months” on the possibility of introducing user fees to speed the generic approval process, Gary Buehler, the office’s director, disclosed at the 2006 Generic Pharmaceutical Association Fall Technical Conference Oct. 19.