Drugs.com Newsletter Vol 68 - April 2010 RSS News Feeds: http://www.drugs.com/rss.html FEATURED NEWS ------------- Record Number of Americans Got Flu Shots, CDC Says April 2010 - Apparently spurred by concerns about the recently discovered H1N1 swine flu virus, a record number of Americans - especially children and younger adults - got seasonal flu shots during the just-concluded flu season, health officials reported Thursday Read more: http://www.drugs.com/news/record-number-americans-got-flu-shots-cdc-says-24139.html NEW DRUG APPROVALS ------------------ The following drugs have recently been approved by the FDA. Provenge (sipuleucel-T) Suspension for Intravenous Infusion http://www.drugs.com/provenge.html Date of Approval: April 29, 2010 Treatment for: Prostate Cancer Provenge Drug Information: http://www.drugs.com/provenge.html Press Release: http://www.drugs.com/newdrugs/fda-approves-provenge-cellular-immunotherapy-men-advanced-prostate-cancer-2130.html Zortress (everolimus) Tablets http://www.drugs.com/zortress.html Date of Approval: April 22, 2010 Treatment for: Organ Transplant -- Rejection Prophylaxis Zortress Drug Information: http://www.drugs.com/zortress.html Press Release: http://www.drugs.com/newdrugs/novartis-receives-us-fda-approval-zortress-everolimus-prevent-organ-rejection-adult-kidney-2123.html Oravig (miconazole) Buccal Tablets http://www.drugs.com/oravig.html Date of Approval: April 16, 2010 Treatment for: Oral Thrush Oravig Drug Information: http://www.drugs.com/oravig.html Press Release: http://www.drugs.com/newdrugs/fda-approves-oravig-miconazole-buccal-oropharyngeal-candidiasis-2114.html Pancreaze (pancrelipase) Delayed-Release Capsules http://www.drugs.com/pancreaze.html Date of Approval: April 12, 2010 Treatment for: Pancreatic Exocrine Dysfunction Pancreaze Drug Information: http://www.drugs.com/pancreaze.html Press Release: http://www.drugs.com/newdrugs/fda-approves-pancreatic-enzyme-product-pancreaze-2111.html New Indications and Dosage Forms -------------------------------- Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. OxyContin (oxycodone) Controlled-Release Tablets http://www.drugs.com/oxycontin.html New Formulation Approved: April 5, 2010 Now Approved: New Formulation (to discourage misuse and abuse) OxyContin Drug Information: http://www.drugs.com/oxycontin.html Press Release: http://www.drugs.com/newdrugs/fda-approves-new-formulation-oxycontin-2106.html Tarceva (erlotinib) Tablets http://www.drugs.com/tarceva.html New Indication Approved: April 16, 2010 Now Approved for: Maintenance Treatment of Advanced Non-Small Cell Lung Cancer Tarceva Drug Information: http://www.drugs.com/tarceva.html Press Release: http://www.drugs.com/newdrugs/fda-approves-tarceva-maintenance-therapy-advanced-non-small-cell-lung-cancer-2118.html First-Time Generic Approvals ---------------------------- First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace. Temozolomide Capsules 5 mg, 20 mg, 100 mg, 250 mg, 140 mg and 180 mg Approved: March 1, 2010 Barr Pharmaceuticals, Inc. Generic for: Temodar Tamsulosin Hydrochloride Capsules 0.4 mg Approved: March 2, 2010 Impax Laboratories, Inc. Generic for: Flomax Dactinomycin Injection 0.5 mg/vial Approved: March 16, 2010 Bedford Laboratories Generic for: Cosmegen Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets 180 mg / 240 mg Approved: March 17, 2010 Company: Dr. Reddy's Laboratories Limited Generic for: Allegra-D 24 Hour Metaxalone Tablets 800 mg Approved: March 31, 2010 Company: Sandoz Inc. Generic for: Skelaxin Read more: http://www.drugs.com/generic-approvals.html OTHER DRUG NEWS --------------- Interrupting a Nurse Makes Medication Errors More Likely http://www.drugs.com/news/interrupting-nurse-makes-errors-more-likely-24051.html Four Unhealthy Behaviors Linked to Premature Death http://www.drugs.com/news/four-unhealthy-behaviors-linked-premature-death-24049.html Time to Remind Teens About Sun Protection http://www.drugs.com/news/time-remind-teens-sun-protection-24028.html Review Panel Leaves Controversial Lyme Disease Guidelines Unchanged http://www.drugs.com/news/review-panel-leaves-controversial-lyme-guidelines-unchanged-24001.html Flying With Needles and Meds Can Raise Security Flags http://www.drugs.com/news/flying-needles-meds-can-raise-security-flags-23981.html Supplements Might Reduce Breast Cancer Risk http://www.drugs.com/news/supplements-might-reduce-breast-cancer-risk-23877.html Kids' Suicide Risk Same for All Antidepressants http://www.drugs.com/news/kids-suicide-risk-same-all-antidepressants-23744.html Prescriptions Translated to Spanish Could Be Hazardous to Health http://www.drugs.com/news/prescriptions-translated-spanish-could-hazardous-health-23702.html Chemicals in Beauty Products Tied to Early Puberty in Girls http://www.drugs.com/news/chemicals-beauty-products-tied-early-puberty-girls-23690.html Insight on Herbals Eludes Doctors, Patients Alike http://www.drugs.com/news/insight-herbals-eludes-doctors-patients-alike-23678.html Cancer Vaccines May Be On The Verge Of Wider Use http://www.drugs.com/news/cancer-vaccines-may-verge-wider-23653.html Prescription Drug Abuse Sending More to Hospitals http://www.drugs.com/news/abuse-sending-more-hospitals-23627.html Vaccines-By-Patch Good News for Needle-Phobic http://www.drugs.com/news/vaccines-patch-good-news-needle-phobic-23613.html More news headlines: http://www.drugs.com/news.html FDA MEDWATCH ALERTS -------------------Boxed Warning for Propylthiouracil http://www.drugs.com/fda/propylthiouracil-12720.html Recall: Atlas Operations, Inc. Sexual Enhancement Products http://www.drugs.com/fda/atlas-operations-inc-recall-sexual-enhancement-products-12719.html Heparin: Change in Reference Standard http://www.drugs.com/fda/heparin-change-reference-standard-12717.html Voluntary recall: Camolyn eye drops and Fisiolin nasal drops http://www.drugs.com/fda/camolyn-eye-drops-fisiolin-nasal-drops-voluntary-recall-due-non-sterility-12716.html Recall: Stud Capsule For Men http://www.drugs.com/fda/stud-capsule-men-product-contains-undeclared-ingredient-12715.html More FDA Medwatch Alerts: http://www.drugs.com/fda_alerts.html TOOLS & HELPFUL LINKS --------------------- Community Discussion Forums - We welcome you to share your experiences. http://www.drugs.com/forum/ Medical Encyclopedia - Use this feature to find information on diseases, symptoms, injuries, medical tests and surgical procedures. http://www.drugs.com/enc_index.html Browse by Medical Condition - Use this feature to find drugs or medication related to a condition or therapeutic group. http://www.drugs.com/medical_conditions.html Pill Identifier - The Pill Identifier enables a search for unidentified pills by imprint code or shape/color. http://www.drugs.com/pill_identification.html Drug Interactions Checker - Increasingly popular as more healthcare professionals and consumers make the effort to seek detailed information on drug-drug and drug-food interactions. http://www.drugs.com/drug_interactions.html New Drugs - All the latest information on FDA Approvals and recent additions to the database. http://www.drugs.com/newdrugs.html News & Articles - Roundup of recent drug-related news and press releases. also latest news from FDA Medwatch service including timely publication of recalls, withdrawals, warnings, and label/packaging changes. http://www.drugs.com/news.html ABOUT THIS NEWSLETTER --------------------- Drugs.com is not affiliated with any pharmaceutical company. 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