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Barr Pharmaceuticals’ tentative approval for a generic version of Bristol-Myers Squibb’s diabetes drug Glucophage XR has been withdrawn by the FDA because of concerns over the pharmaceutical ingredients used to make the product, the firm said Jan. 9.
In a move that could delay generic competition, Purdue Pharma has petitioned the FDA to withhold final approval for a version of its profitable pain drug OxyContin until generic firms implement appropriate risk management plans (RMPs).
The FDA has withdrawn its tentative approval for Barr Pharmaceuticals’ generic version of Bristol-Myers Squibb’s diabetes drug Glucophage XR because of concerns over the pharmaceutical ingredients used to make the product, the firm said Friday.
The FDA’s anticounterfeiting initiative and the growing trend of drugmakers’ exerting control over their distribution chains should get a boost from model state rules being developed to beef up oversight of drug wholesale distributors.
A New York institutional review board (IRB) may be disqualified if it does not correct several violations cited during a recent FDA inspection, placing all current device research under its oversight in jeopardy.
The FDA is withholding final approval of Staar Surgical’s premarket approval application (PMA) for its implantable contact lens (ICL) while the company implements better procedures for filing medical device reports (MDRs).
The FDA's 11-year ban on silicone breast implants will continue under stricter approval guidelines on safety and effectiveness, which were developed, in part, in response to data submitted by Inamed.
The FDA has told Xcel Pharmaceuticals that its promotional materials for two migraine products omit risk information, make misleading comparative claims about safety and include unsubstantiated efficacy and indication claims.
Due to income that the Internal Revenue Service (IRS) says was improperly shifted to other countries, GlaxoSmithKline (GSK) allegedly owes the U.S. government $2.7 billion in unpaid taxes, the company confirmed last week.