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The FDA has approved labeling revisions to antidepressants, clearing the way
for drugmakers to add required "black box" warnings to their products
to describe the increased risk of suicidal behavior in children and adolescents
who take the drugs.
A joint panel of FDA advisers has recommended the agency not approve Merck's
application to convert its cholesterol-lowering statin Mevacor from prescription
to OTC status -- a move that will likely dampen efforts for OTC switches of other
statins that are set to lose patent protection.
The FDA has withdrawn a direct final rule to incorporate
exemptions from the Freedom of Information Act (FOIA) into the agency's public
information regulations because of what the agency called "significant
adverse" comments from the public.
A California state bill requiring drugmakers to turn over all safety and effectiveness
data on every drug product sold in the state is part of a batch of Rx-related
legislation that California lawmakers are scheduled to address this session.
The Serious Fraud Office is investigating a division of Novartis, one of the
world's largest pharmaceutical firms, for alleged criminal marketing practices
as part of its investigation into alleged price-fixing by drugs companies.
Akesis Pharmaceuticals (formerly known as Liberty Mint) has completed the acquisition
of Akesis Pharmaceuticals (Delaware) and named key employees and directors of
the post merger company.
The Mumbai-based Eisai Pharmaceuticals India has identified Wockhardt as the
company's partner for the manufacture of its Alzheimer's drug Aricept (donepezil
hydrochloride tablets) in India.
Cipher Pharmaceuticals will sell its Pharma Medica Research division to the
current management team of Pharma Medica for $19.1 million, the company said.
Cardinal Health, the leading provider of products and services supporting the
healthcare industry, has reached agreement with Eisai to provide distribution
services for Eisai's life-enhancing therapies.
CollaGenex Pharmaceuticals has said it intends to seek "prompt injunctive
relief" to protect its patent and intellectual property rights following
a decision by the U.S. District Court for the District of Columbia.