Senate, House authorize added funds for FDA
WASHINGTON The Senate Appropriations Committee passed an amendment last week granting the Food and Drug Administration an immediate $275 million infusion.
The amendment, also passed by the House last Thursday, stipulates that $48.5 million be used for Center for Drug Evaluation and Research operations and related field activities for the Office of Regulatory Affairs; $23.5 million for the Center for Biologics Evaluation and Research and related ORA activities; and $21.8 million for the FDA Office of the Commissioner, Office of Operations, Office of Scientific and Medical Programs, Office of International and Special Programs and Office of Policy, Planning and Preparedness. The remainder is to be used for the Center for Food Safety and Applied Nutrition and other activities.
The amendment makes the $275 million available through the end of fiscal 2009 and stipulates that $100 million must be used for drug, device and biologic safety activities, $40 million for modernizing the agency’s science and workforce, $10 million for capital spending on laboratory facilities outside the Washington, D.C., area and $125 million for food protection.
The FDA’s money is in one of three amendments passed by the Senate committee, which has sent them to Senate leaders who may introduce them as legislation this week. The other two amendments involve policy and funding for the war in Iraq.
The House has voted on its versions of the three amendments, approving the one with funding for the FDA.
Santen completes Phase III testing of eye drug
NEW YORK Inspire Pharmaceuticals announced Friday a $1.25 million milestone payment from Japan-based company Santen Pharmaceutical for the completion of Phase III testing of the eye drug diquafosol tetrasodium, also known as DE-089. The two companies have a collaborative agreement to develop the drug.
DE-089 is designed to treat such eye-surface diseases as dry eye. Santen expects to file for marketing approval in Japan by June, and also plans to market the drug throughout Asia. Pending approval of DE-089 by regulatory agencies, Santen will market the drug while Inspire will receive royalties on net sales.
New York-based Inspire discovers, develops and commercializes ocular and respiratory drugs. Santen specializes in ocular and anti-rheumatic drugs and had headquarters in Osaka, Japan.
Salix receives FDA approvable letter for Balsalazide colitis treatment
RALEIGH, N.C. Salix Pharmaceuticals has received an approvable letter from the Food and Drug Administration for its ulcerative colitis drug Balsalazide Tablet NDA, the company announced May 16. The drug is designed to treat mild-to-moderate active ulcerative colitis in patients 18 years and older. The disease causes ulcers in the lining of the rectum and colon.
Salix has headquarters in Raleigh, N.C., and specializes in drugs to treat gastrointestinal disorders. The company markets such drugs as Colazal (balsalazide disodium) capsules 750 mg, Xifaxan (rifaximin) tablets 200 mg, Osmoprep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) tablets and Moviprep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution.