FDA Approvals

FDA Approves Methylphenidate Patch for Teens With ADHD The FDA has approved an expanded age range for a methylphenidate transdermal system for the treatment of ADHD in adolescents aged 13 to 17 years.
News, July 09, 2010
FDA Approves 7-Day Buprenorphine Pain Patch The FDA has approved a once-weekly buprenorphine transdermal system for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic.
News, July 08, 2010
FDA Clears Liquid-Cooled Fiber for Benign Prostatic Hyperplasia The FDA has granted 510(k) clearance for a liquid-cooled fiber to be used with the company's recently launched 180-watt laser system for the treatment of benign prostatic hyperplasia.
News, July 07, 2010
FDA Clears 2-Sided Ventral Hernia Repair Mesh The FDA has granted 510(k) clearance for a 2-sided ventral hernia repair mesh for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.
News, July 01, 2010
FDA Clears Updated Single-Incision Female Sling System for Incontinence The FDA has granted 510(k) clearance for a next-generation single-incision sling system for female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
News, June 30, 2010
FDA Clears Handheld Needleless Hemoglobin Spot-Check Device The FDA has granted 510(k) clearance for a handheld device for noninvasive hemoglobin spot-check testing, along with Sp02, pulse rate, and perfusion index, in virtually any environment.
News, June 30, 2010
FDA Clears Dual Molecular Diagnostic Test for Chlamydia/Gonorrhea The FDA has granted 510(k) clearance for an in vitro PCR assay and an automated instrument for the simultaneous detection of gonorrhea and chlamydia in symptomatic and asymptomatic individuals.
News, June 30, 2010
Generic Versions of Anastrozole Now Available in US Generic versions of this aromatase inhibitor will reduce the cost of adjuvant hormonal therapy for breast cancer, which is continued for 5 years.
News, June 30, 2010
FDA Approves First Generic Venlafaxine Extended-Release Capsules The FDA has approved the first generic version of venlafaxine HCl capsules for the treatment of major depressive disorder.
News, June 29, 2010
FDA Approves Mometasone-Formoterol Combo for Asthma The FDA has approved mometasone furoate and formoterol fumarate dihydrate inhalation aerosol for the treatment of asthma in patients aged 12 years and older.
News, June 28, 2010
FDA Clears Updated Revascularization Catheter for Below-the-Knee Blockages The FDA has granted 510(k) clearance for a new version of a peripheral revascularization catheter for the treatment of peripheral vascular disease below the knee.
News, June 28, 2010
FDA Approves First Rapid HCV Antibody Test The FDA has approved the first rapid blood test for antibodies to the hepatitis C virus in patients aged 15 years and older who are at risk for HCV or have signs/symptoms of hepatitis.
News, June 28, 2010
FDA Approves Ranibizumab for Sudden Blindness Indication Ranibizumab intravitreal injection (Lucentis) has been approved for the treatment of macular edema after retinal vein occlusion.
News, June 24, 2010
FDA Approves First Generic Formulation for Azactam The FDA has approved the first generic formulation of aztreonam injection.
News, June 24, 2010
FDA Approves CDC's Optimized H1N1 Test The FDA has cleared a new test developed by the CDC for the diagnosis of infections caused by the 2009 H1N1 influenza virus, formerly known as "swine flu" or "pandemic H1N1 flu."
News, June 23, 2010
FDA Approves Extended-Release Memantine for Moderate to Severe Dementia of the Alzheimer's Type Forest and Merz announced FDA approval of the extended-release formulation of memantine (NAMENDA XR).
News, June 22, 2010
FDA Approves Novel Early Detection HIV Test The FDA has approved the first assay to detect the HIV p24 antigen as well as antibodies to HIV types 1 and 2, potentially allowing patients to be diagnosed days earlier than with antibody-only tests.
News, June 22, 2010
Nilotinib Receives Front-Line Approval for CML The US Food and Drug Administration has approved nilotinib as a first-line therapy for patients newly diagnosed with chronic myeloid leukemia (CML).
News, June 21, 2010
FDA Approves Dutasteride/Tamsulosin Combo Pill for BPH The FDA has approved a single-capsule formulation of 0.5 mg dutasteride and 0.4 mg tamsulosin for symptomatic BPH in men with an enlarged prostate.
News, June 18, 2010
Cabazitaxel: New Chemo Approved for Advanced Prostate Cancer The new drug is approved for second-line use in advanced hormone-refractory prostate cancer, after progression on docetaxel.
News, June 18, 2010

No Results