A study by the Kaiser Family Foundation shows that the Medicare prescription drug plan for seniors and the disabled is providing substantial discounts on drugs. In its report, the organization finds that
The United States Food and Drug Administration has approved Campral (acamprosate calcium) tablets which help recovering alcoholics to stay off the drink. Campral is manufactured by Forest Laboratories and
The U.S. Food and Drug Administration has issued a public warning regarding counterfeit versions of the drugs simvastatin and carisoprodol that have recently been imported from Mexico to the U.S.
Pharmaceutical manufacturer Schering Plough will reimburse Washington's Medicaid program $3.57 million in a nationwide settlement of allegations the drug maker failed to offer state Medicaid progra
New data published in the August issue of SLEEP shows that patients with primary Restless Legs Syndrome (RLS) and with periodic leg movements during sleep (PLMS), have fewer awakenings resulting from involuntary kicks when treated with
Schering-Plough has announced that the Committee for Medicinal Products for Human Use of the European Agency for the Evaluation of Medicinal Products has issued a positive opinion recommending appr
Roche has announced results from a study demonstrating that the new boosted dosing regimen for its protease inhibitor Invirase(R) (saquinavir 1000 mg with ritonavir 100 mg twice-daily) has no signific
Texas Attorney General Greg Abbott has announced a settlement among Texas and other states with pharmaceutical giant Schering-Plough Inc. that will return more than $9 million to the Texas Medicaid program for the company's fraudulent reporting of pric
The Food and Drug Administration has announced approved Epzicom (abacavir/lamivudine) and Truvada (tenofovir disoproxil/emtricitabine), two fixed-dose combination treatments for HIV-1 infection. C
A drug that improves function of retinal blood vessels may be able to reduce the risk of stroke, according to a report in today's rapid access issue of Stroke: Journal of the American Heart Association.The small study found that endothelial funct
Nascobal Nasal Spray was developed by Nastech as an alternative to Nascobal Nasal Gel and worldwide marketing rights to both products were divested to Questcor Pharmaceuticals, Inc. in June 2003. Nastech will manufacture the product for Questcor following final approval by the FDA under terms of a supply agreement with Questcor.
Remaining items to be completed for product approval are an FDA inspection of a supplier's B-12 raw material manufacturing facility and finalization of the product labeling. There were no FDA requirements for additional work related to manufacturing, preclinical, or clinical studies.
"We are encouraged by the timely review of the Nascobal Nasal Spray application by the FDA and we believe that we can close these issues resulting in NDA approval in the near future," said Gordon C. Brandt, M.D., Executive Vice President, Clinical Research and Medical Affairs of Nastech. "FDA approval of this application will potentially provide the approximately 116,000 patients who currently receive monthly intramuscular B-12 injections with access to a more convenient, patient friendly treatment for vitamin B-12 deficiency."
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