FDA Approvals

FDA Approves Tapentadol for Chronic Pain Tapentadol extended release, already approved for acute pain, has now been given the go ahead for chronic pain.
News, August 26, 2011
FDA Approves New Drug for Hereditary Angioedema Icatibant injection, now indicated for acute attacks in adults aged 18 years and older, can reduce attack symptoms by half in 2 hours, studies show.
News, August 25, 2011
FDA Approves Combination Drug for Pediatric HCV Infection The addition of ribavirin to peginterferon alfa-2a significantly improves response rates, a new study shows.
News, August 24, 2011
FDA Approves Brentuximab for Refractory Lymphomas Study data reveal a high response rate for patients with refractory Hodgkin's and systemic anaplastic large cell lymphoma.
News, August 19, 2011
FDA Approves Zelboraf (Vemurafenib) for Metastatic Melanoma Clinicians now have another option for the treatment of advanced melanoma.
News, August 17, 2011
FDA Approves Mometasone Implant for Chronic Sinusitis The FDA has approved a novel implantable delivery system for mometasone furoate that provides controlled drug delivery for patients with chronic sinusitis.
News, August 15, 2011
Once-Daily Triple HIV Drug Receives FDA Approval The FDA has granted approval of emtricitabine/rilpivirine/tenofovir (Complera), a once-daily, triple-drug combination treatment for treatment-naive patients with HIV.
News, August 10, 2011
FDA Clears New Competitor to the 3T MR Market FDA approves new competitor to the 3T MR market.
News, August 10, 2011
FDA Approves First-Ever Antivenom for Scorpion Stings The antivenom, Anascorp, reverses symptoms within hours, spares children days in the intensive care unit.
News, August 04, 2011
FDA Approves Fingolimod Update in Prescribing Information The FDA has approved a supplemental new drug application for fingolimod to include data on T1 gadolinium-enhancing MRI in the prescribing information.
News, August 02, 2011
FDA Approves Subcutaneous Abatacept for RA Once-weekly subcutaneous abatacept has been approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe rheumatoid arthritis.
News, August 02, 2011
IncobotulinumtoxinA Gets FDA Okay for Frown Lines The US Food and Drug Administration has approved incobotulinumtoxinA for a temporary improvement in the appearance of moderate to severe glabellar lines.
News, July 21, 2011
FDA Approves Imiquimod 2.5% for Actinic Keratosis Imiquimod cream 2.5% has received FDA approval for the treatment of actinic keratosis.
News, July 19, 2011
Once-Daily Mesalamine Approved for UC Remission Maintenance The US Food and Drug Administration has approved once-daily mesalamine delayed-release tablets for the maintenance of remission in patients with ulcerative colitis.
News, July 18, 2011
FDA Approves Tdap Booster for Seniors The tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine marketed as Boostrix has received expanded approval to include adults aged 65 and older.
News, July 08, 2011
FDA Clears First Antiviral Surgical Mask In in vitro tests, the BioMask deactivates influenza virus with a copper and zinc ion filter.
News, July 05, 2011
FDA Approves Once-Daily Bronchodilator for COPD As a once-a-day drug, the new long-acting beta2-adrenergic agonist promises greater patient adherence than twice-daily LABAs.
News, July 01, 2011
FDA Approves First Fentanyl Nasal Spray for Cancer Pain The FDA has approved the first fentanyl nasal spray to treat breakthrough pain in cancer patients who are opioid tolerant.
News, June 30, 2011
FDA Approves New Drug for Chronic Anal Fissure Pain The FDA has approved Rectiv for the treatment of pain associated with chronic anal fissures; the ointment has been in use in Europe and 34 other countries for some years.
News, June 22, 2011
FDA Okays First Autologous Filler for Smile Lines The US Food and Drug Administration has approved the first autologous filler for nasolabial fold wrinkles in adults.
News, June 22, 2011

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