Regulatory Affairs Syndicator

Many medications are approved by the U.S. Food and Drug Administration on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found.

WASHINGTON (AP) _ The Food and Drug Administration said Thursday it is investigating a possible link between Merck’s best-selling Singulair and suicide.

According to the Food and Drug Administration’s (FDA) Internet site, the government agency is investigating Merck’s (MRK: sentiment, chart, options) Singulair asthma drug…( Read More )

President Bush’s choice to head the Food and Drug Administration is refusing to give Congress all the information it seeks about a controversial antibiotic, setting up further confrontations with a Republican senator blocking his nomination.

The world’s biggest drug firm led a sales force arms race, now it is cutting its army of salespeople by 20%.

DUBLIN, Ireland—-Research and Markets has announced the addition of “Advances in Food Safety ” to their offering.

Pfizer Inc. should get U.S. approval to market its Celebrex arthritis-pain pill for use in children because the benefits outweigh the risks, a Food and Drug Administration advisory panel said Wednesday.

Diagnostics and drug developer Akorn Inc. said Thursday the Food and Drug Administration granted its generic version of Novartis’ Voltaren ophthalmic solution tentative approval.

Study: Drug-coating increases risk fivefold With a new report blaming drug-coated heart stents for a fivefold increase in the risk of clotting problems and a Food and Drug Administration panel poised to investigate the devices next week, hospitals that once embraced the new stents are starting to retreat to an older, cheaper version.

BUFFALO GROVE, Ill.—-Akorn, Inc. today announced that the U.S. Food and Drug Administration has granted tentative approval for Akorn’s Abbreviated New Drug Application for Diclofenac Sodium Ophthalmic Solution 0.1% in 2.5 ml and 5 ml dropper bottles.

Tokyo, Nov 30, 2006 (JCN) - Daiichi Sankyo announced November 29 that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for a fixed dose combination of two antihypertensives, the calcium channel blocker (CCB) amlodipine besylate (currently marketed by Pfizer as Norvasc) and the angiotensin receptor blocker (ARB) olmesartan medoxomil, or Benicar.

They want Pentagon to determine if Factor VII’s risks outweigh benefits Two U.S. senators called on the Pentagon yesterday to investigate the military’s use of a largely experimental blood-coagulating drug that doctors inject into wounded troops to control bleeding but that has been linked to unexpected and potentially deadly blood clots.

Study: Drug-coating increases risk fivefold With a new report blaming drug-coated heart stents for a fivefold increase in the risk of clotting problems and a Food and Drug Administration panel poised to investigate the devices next week, hospitals that once embraced the new stents are starting to retreat to an older, cheaper version.

The Croatia-based Pliva, the subsidiary of the New Jersey-based Barr Pharmaceuticals Inc, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market pravastatin tablets 10 mg, 20 mg, and 40 mg, the generic version of Bristol-Myers Squibb’s Pravachol (pravastatin sodium) tablets.

Children as young as 2 who suffer from arthritis can be treated with Celebrex, but to ensure the painkiller doesn’t put them at later risk for heart attacks, their health should be tracked for decades, a Food and Drug Administration advisory panel said Wednesday.