Baxter Healthcare Corp., which produces about 50% of the heparin drug sold in the U.S., has halted the production of the drug’s multi-dose injectable form, following reports of serious allergic reactions in several patients. The death of four patients may also be linked to the drug.

The FDA said that most of the reactions, such as breathing difficulty, excessive sweating, nausea and falling blood pressure, had been in patients receiving a high dose. Heparin is a blood thinner used to prevent blood clots in patients undergoing kidney dialysis and heart surgery.

Chattem Inc. has voluntarily recalled its Icy Hot Heat Therapy products, following reports of skin irritation and first, second and third degree burns. The recalled products include Icy Hot Heat Therapy Air Activated Heat – Back, Icy Hot Heat Therapy Air Activated Heat – Arm, Neck, and Leg and Icy Hot Heat Therapy Air Activated Heat – Arm, Neck, and Leg single consumer use (samples). Company spokesperson Catherine Baker said, “Because we are unsure if it is misuse or not, we’re going to study that before we make the decision to put the product back on the market or not.”

APP Pharmaceuticals Inc. has received FDA approval for two generic dugs. The regulatory agency has approved APP Pharma’s Abbreviated New Drug Application (ANDA) for Caffeine Citrate Oral Solution, 20 mg/ml, which is a generic version of Bedford Laboratories’ Cafcit Oral Solution used for the short-term treatment of apnea in premature infants. The FDA has also approved the ANDA for bleomycin sulfate for injections, the generic version of Bristol-Myers Squibb’s cancer treatment drug Blenoxane.

Medtronic Inc. has received FDA approval for RestoreULTRA, an implantable neurostimulation system device for the treatment of chronic, troublesome pain in the back and leg. Patients can adjust the stimulations produced by the rechargeable device according to fluctuations in pain through a remote control, apart from directing the stimulations at a specific point in the spinal cord. The company plans to make the device available in the U.S. by the end of February.

MiddleBrook Pharmaceuticals has received FDA approval for its amoxicillin extended-release drug. The once-daily treatment for pharyngitis and/or tonsillitis (commonly referred as strep throat), to be marketed under the brand name Moxatag, has been approved for adults and children over 12 years of age. The market launch of the drug, which is the first product based on MiddleBrook’s time-release technology (called Pulsys), is expected in October or November 2008.

An FDA panel unanimously supported the approval of a long-acting, injectable form of Eli Lilly & Co.’s Zyprexa (olanzapine) drug for the treatment of schizophrenia patients. The panel of outside medical experts said the injectable formulation was “acceptably safe” for stable patients or those suffering from acute attacks. The rare risk of patients experiencing excessive sedation or even coma after the administration of the injection is acceptable, considering the effectiveness of the drug. All patients recovered fully and the use of the drug has been continued for most of them. Zyprexa is currently approved in the oral and short-acting injectable forms.

Merck & Co.’s Fosamax (alendronate sodium) now has competition. Teva Pharmaceutical Industries Ltd. has received FDA approval for a generic version of Fosamax for osteoporosis treatment. The generic has been approved in doses of 5 mg, 10 mg, 35 mg, 40 mg and 70 mg. The company has marketing exclusivity for 180 days and plans to commence shipment of the drug immediately.

Patients are at a higher risk of a cardiovascular incident and maybe even death during the first three months after they stop taking Sanofi-Aventis’ Plavix, according to a new research published in the Journal of the American Medical Association. Patients who have suffered a heart attack or have received a stent are put on Plavix (clopidogrel), which prevents the formation of blood clots. Dr. P Michael Ho, a lead author of the report, said, “It was almost a twofold increased risk in that initial period compared to later follow-up periods.”

The FDA has delayed the final approval of GlaxoSmithKline Plc’s Requip XL. The drug is a once-a-day oral treatment for Parkinson’s disease, a progressive neurological disorder that slows body movement. The delay affects SkyePharma Plc, since it uses the company’s slow release technology. The FDA is expected to announce a decision on the drug’s approval in the second quarter of this year.

It is expected that the current robotics market, which hit $626.5 million in 2007, will reach an incredible $1 billion by 2008, and is estimated to rise to $14 billion by 2014.

Behind this phenomenal growth is the evolution of the robotics technology into maturity and economic feasibility. Systems are becoming more adaptable to individual needs. Applications are expanding outside of the operating room and into the home and research labs, allowing for greater possibilities and higher revenues. 

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