The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities.
Amneal Pharmaceuticals announced four new additions to its portfolio of generic drugs, which represent multiple therapeutic categories and account for $900 million annually in U.S. sales, the company said, citing data from IMS Health.
A survey co-released by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.
Ohm Labs, a wholly owned subsidiary of Ranbaxy Labs, on Friday announced that it received approval from the Food and Drug Administration to manufacture and market valsartan tablets in 40 mg, 80 mg, 160 mg and 320 mg dosage strengths.
Canada’s Federal Court ruled recently that the country’s Patented Medicine Prices Review Board — a federal tribunal that regulates pricing on branded medicines — could not extend price-control measures to cover generic drug companies, according to published reports.
A survey co-released on Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that the healthcare providers patients rely on most to explain safety information about their prescription drugs have serious concerns about a proposed FDA rule on generic drug labeling.
A survey co-released Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.
Canada’s Federal court ruled recently that the country’s Patented Medicine Prices Review Board – a federal tribunal that regulates pricing on branded medicines – could not extend price control measures to cover generic drug companies.
The Generic Pharmaceutical Association lobbied for greater access to generics at this week’s meeting of the chief negotiators of the Trans-Pacific Partnership in Ho Chi Minh City, Vietnam, the association announced Wednesday.
Mylan last week announced that it filed suit against the Food and Drug Administration, challenging the agency's decision regarding generic drug marketing exclusivity on celecoxib capsules, the generic equivalent of Pfizer's Celebrex.
By adding complementary specialty medication offerings to their generic drug businesses, manufacturers can add instant value and counteract the margin compression that is currently occurring as a result of high generic drug utilization.
Prescription drug trend grew 3.8% in 2013, driven by significant price inflation for traditional brand drugs, specialty drugs and generics, as well as an increase in utilization as members filled more prescriptions in the slowly improving economy, according to the findings of CVS Caremark’s annual "Insights" report released on Thursday.
Last year, $29.3 billion was spent on prescription drugs in Canada, but the annual growth rate was the second-lowest in more than 20 years, according to a new report by the Canadian Institute for Health Information released earlier this month.