Antibiotic voluntarily recalled by Ranbaxy
PRINCETON, N.J. All supplies of an antibiotic will be recalled amid concerns that it could cause nausea and vomiting.
Ranbaxy Pharmaceuticals announced last week that it would voluntarily recall all lots of the drug Nitrofurantoin (monohydrate and macrocrystals) capsules in the 100-mg strength.
The company said some lots were defective, but decided to recall all lots as a precaution. The company, based in Gurgaon, India, said it is conducting the recall in coordination with the Food and Drug Administration at the retail level. Recalled lots of the drug are unlikely to produce serious adverse effects, Ranbaxy said, but a remote possibility exists of nausea and vomiting. The company said patients using the drug should consult their physicians about alternative medication options.
Investigational oxycodone formulation may discourage drug abusers
NEW ORLEANS Two drug companies may have developed a formulation of the painkiller oxycodone that discourages drug abusers.
King Pharmaceuticals and Acura Pharmaceuticals announced Friday that results from an oral abuse liability study of the drug Acurox (oxycodone hydrochloride and niacin) tablets indicate they are disliked among people with a history of opioid abuse, compared with oxycodone tablets alone when they swallow excess doses.
“The fact that people with a history of opioid abuse showed a disliking of Acurox tablets in excessive doses is an indication that the product is an important step in the development of medicines that are designed to deter common methods of abuse, such as over ingestion, while effectively managing pain,” lead study author and chief of Johns Hopkins Bayview Medical Center’s Center for Chemical Dependence Donald Jasinski said.
Results of the study were presented Friday at the American Society of Addiction Medicine’s Medical-Scientific Conference.
The two companies said the Food and Drug Administration had given Acurox priority review classification, and they expect to get a response from the FDA by June 30.
Amylin issues letter to shareholders regarding board of directors
SAN DIEGO Drug maker Amylin Pharmaceuticals is urging shareholders to reject prospective members of its board nominated by investor Carl Icahn and Eastbourne Capital Management.
Amylin sent a letter to shareholders Friday, signed by president and CEO Daniel Bradbury and lead independent director James Wilson, requesting that they instead vote for the company’s current board, saying the company was “poised to revolutionize” Type 2 diabetes treatment with the once-weekly formulation of the drug Byetta (exenatide), currently awaiting approval by the Food and Drug Administration. The FDA approved the twice-daily formulation of the drug in 2005.
“To ensure that you benefit from this value opportunity, it is imperative that Amylin has the best possible board of directors,” Bradbury and Wilson wrote in the letter.