OSCO NEWS

FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain - The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL. read more

2010 PQRI standards for oncology - read more

Related Website: http://www.cms.hhs.gov/PQRI/Downloads/2010PQRIMeasSpecManlforClaimsRegisReptgIndivlMeasRelNotes_122109.zip

Pralatrexate Injection (Folotyn) - On September 24, 2009, the Office of Oncology Drug Products granted accelerated approval to pralatrexate injection (FOLOTYN, Allos Therapeutics, Inc.) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This approval was based on an overall objective response rate observed in a single-arm trial. As a condition of the accelerated approval, randomized, controlled trials are required post-approval to verify and describe the clinical benefit of pralatrexate in PTCL. read more

Related Website: http://rs6.net/tn.jsp?et=1102732188478&s=869&e=0016VLN9R4NSDByfu8tM841Y7gQu9hivcT7zS6XyMzWpeixsatKDCILvzMYZShLUTtZFr13NxvaPccgsiiHtnyw0kt080kRK5VKhHyVro1wQzcbN-X0tG_guoX1bZbYjLY06-iwN3iAq0IViYTpqKD1a9

FDA Clears a Test for Ovarian Cancer - FDA Clears a Test for Ovarian Cancer Test can help identify potential malignancies, guide surgical decisions The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom. read more

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection - FDA Requires Boxed Warning for Promethazine Hydrochloride Injection The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA's authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting. read more

FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs - The U.S. Food and Drug Administration published two rules today that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don't have other satisfactory treatment read more

Related Website: http://rs6.net/tn.jsp?et=1102669039544&s=869&e=001FOqARcOkc-bBZiu22ed-GETyYZimkCzmIXcB5QOCBk9WwAi6GUQpRp9h3TDB6npuyzL6K52M20L7roTbjEwFLdN60Vtlc61aKRUdtKEmDvzUP8u6-s8xKlTDVY-bY5sWTZlDvT6wdHVDKaiAfpBL0W

Reporting Non-Tax Withholding Due to Federal Payment Levy Program (FPLP) - Reporting Non-Tax Withholding Due to Federal Payment Levy Program (FPLP) Reference: Trans. 503, CR #6228, Pub. 100-20, MLN: MM6228 Published Online: 8/14/2009 Provider Types Affected Physicians and providers who bill Medicare carriers, fiscal intermediaries (FI), and Medicare Administrative Contractors (MAC) for services provided to Medicare beneficiaries. read more

New Rx for Health Plan: Split Bill - By JONATHAN WEISMAN and NAFTALI BENDAVID The White House and Senate Democratic leaders, seeing little chance of bipartisan support for their health-care overhaul, are considering a strategy shift that would break the legislation into two parts and pass the most expensive provisions solely with Democratic votes read more

updated policy from CMS regarding OncotypeDX- J1 MAC - read more

Related Website: http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=28287&lcd_version=18&show=

FDA Approval for Avastin in Combination with Interferon Alfa - Bevacizumab (Avastin) in Combination with Interferon Alfa On July 31, 2009 the U.S. Food and Drug Administration granted approval for the use of bevacizumab (Avastin, Genentech, Inc.) in combination with interferon alfa for the treatment of patients with metastatic renal cell carcinoma. The approval was based on results from the BO17705 trial which demonstrated a 5 month improvement in median progression-free survival (PFS) in bevacizumab-treated patients. read more

Related Website: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0168lbl.pdf