FDAnews Drug Daily Bulletin

Blocking imports of every shipment of active pharmaceutical ingredient intended for compounding is an impossible feat requiring resources beyond the FDA’s means, the agency told an appeals court last week, calling KV Pharmaceuticals’ claims it should have done so “absurd.”

Ranbaxy subsidiary Ohm Laboratories received a Form 483 for quality control lapses surrounding blue glass in the active pharmaceutical ingredient for atrovastatin calcium tablets.

The FDA on May 8 issued two draft question-and-answer guidances intended to clear up industry confusion about how it charges patients for INDs during clinical trials and how it expands access to such drugs outside of the clinical arena.

Hyderabad-based Dr. Reddy’s welcomes India’s new drug pricing policy as a measure that establishes certainty in the field of pharmaceutical pricing where previously there was none.

Merck is one of the companies at Friday’s GBCHealth Conference working to merge private sector funds to provide needed drugs and supplies to foreign aid recipients.

According to European health promoters, as a consequence of the global economic crisis, many Europeans, especially those in poorer EU states, cannot afford access to treatments.

An Australian federal judge has rejected a settlement between Merck and patients claiming the company’s drug Vioxx gave them heart attacks.

The New England Journal of Medicine took the FDA to task for approving too many drugs that start with these two letters.

Mylan has received final FDA approval for an ANDA for its generic version of AbbVie’s Tricor tablets for reducing LDL cholesterol.