FDA approves two new APP generic medications
SCHAUMBURG, Ill. The Food and Drug Administration approved APP Pharmaceuticals’ new drug applications for caffeine citrate oral solution at 20 milligrams/milliliter and for bleomycin sulfate for injection.
Caffeine citrate oral solution, the generic version of Bedford Labs’ Cafcin, is a treatment used for premature infants who have apnea, a condition where babies stop breathing during sleep for a brief amount of time, according to published reports.
Bleomycin is a treatment for cancer, a generic of Bristol-Myer’s Blenoxane, although it works in combination with other medicines. As a result of the recent FDA approval, APP Pharma stock increased to $10.33, a three-cent increase per share.
Biogen Idec, Icahn trade snipes
CAMBRIDGE, Mass. Biogen Idec chief executive officer Jim Mullen has called statements made by investor Carl Icahn, who said Biogen did not do enough to find a potential buyer last year, “Monday morning quarterbacking,” according to the Boston Globe.
Though Mullen didn’t specifically say Icahn’s name, his comments came just a week after Icahn publicly blasted last year’s efforts as “flawed.” Icahn, who owns more than 4 percent of Biogen’s stock, last month nominated three people to sit on the company’s board, as part of his continuing efforts to pressure it to find a buyer. Recently, Icahn told CNBC that he continues to believe Biogen should be sold to a major pharmaceuticals company.
Mullen said the company would be open to considering takeover offers, but he said it needs to “get back” to running its business. “I don’t think the right way to run the business, for anyone’s sake, is to have a permanent ‘for sale’ sign out on the front lawn,” he said. Mullen also said that problems with the company’s multiple sclerosis drug Tysarbi, which was taken off the market in 2005 because of links to a rare brain disease before being reintroduced in 2006, has kept potential buyers drawn back.
FDA issues adverse reaction warning about Botox
WASHINGTON The Food and Drug Administration has notified the public that Botox, Botox Cosmetic and Myobloc (botulinum toxin type b) have been linked to adverse reactions in patients including respiratory failure and death.
The agency has stated that early indications, based on review of materials, links the reactions to overdosing of the medications and not defects in the products.
The adverse effects were found in FDA-approved and nonapproved products. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of Botox products in children or adults.
The adverse reactions appear to be related to the spread of the drug to areas distant from the site of injection, and copy symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.
The FDA is not advising health care professionals to discontinue prescribing these—Allergan and Solstice Neurosciences—products and stated that it is currently reviewing safety information from clinical studies performed by the manufacturers of the drugs.