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Drug Approvals

FDA Approvals

Welcome to our special section for new drugs and medical devices on the Drug and Medical Device Approval page. Here, you find a summary of drugs and medical devices approved by the Food and Drug Administration (FDA). For more information, click on links to the FDA Web site.

This page was last updated on Jul 10, 2008
Date Generic Name Trade Name Details
June 30, 2008 risperidone Risperdal
June 18, 2008 n/a NeuRx DPS RA/4 Respiratory Stimulation System
June 5, 2008 moxidectin ProHeart 6 Sustained Release Injectable for Dogs
May 20, 2008 alvimopan Entereg
May 9, 2008 factor VIIa NovoSeven RT
May 9, 2008 ropinirole hydrochloride Requip
April 29, 2008 lubiprostone Amitiza
April 29, 2008 n/a LipiScan
April 24, 2008 methylnaltrexone bromide Relistor
April 23, 2008 NA Yulex Patient Examination Glove
April 22, 2008 certolizumab pegol Cimzia
April 21, 2008 NA HeartMate II
April 3, 2008 Rotavirus vaccine Rotarix
March 19, 2008 fibrin sealant, VH S/D 4 Artiss
February 28, 2008 esomeprazole magnesium Nexium
February 27, 2008 rilonacept Arcalyst
February 21, 2008 factor VIII Endeavor Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free
February 7, 2008 decellularized heart valve CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft)
February 6, 2008 alendronate sodium Fosamax
February 1, 2008 drug-eluting stent Endeavor Zotarolimus-Eluting Coronary Stent
January 18, 2008 none available ProFlu
January 18, 2008 none available Ortho Evra Contraceptive Transdermal (Skin) Patch
January 18, 2008 Etravirine Intelence
January 16, 2008 none available Evicel
January 15, 2008 food from animal clones none available
January 14, 2008 none available TOP2A FISH pharmDx test
January 11, 2008 none available OLYMPUS PK System Blood Group and Phenotyping Reagents
January 3, 2008 Respiratory virus test xTAG Respiratory Viral Panel
January 2, 2008 MRSA blood test BD GeneOhm StaphSR test

NOTE: Click on the Details to read the details of the approval.

Date:June 30, 2008
Generic Name:risperidone
Trade Name:Risperdal
Manufacturer :TEVA Pharmaceuticals USA, North Wales, PA
Type of Drug/Product:antipsychotic treatment
FDA Release:The FDA approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder and other psychiatric conditions. The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity.

Date:June 18, 2008
Generic Name:n/a
Trade Name:NeuRx DPS RA/4 Respiratory Stimulation System
Manufacturer :Synapse Biomedical, Inc., Cleveland, OH
Type of Drug/Product:Diaphragm stimulator
FDA Release:The FDA has approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe. This usually requires a full-time connection to a ventilation machine. The NeuRx DPS RA/4 uses four electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction; this stimulation allows the patient to inhale.
Date:June 5, 2008
Generic Name:moxidectin
Trade Name:ProHeart 6 Sustained Release Injectable for Dogs
Manufacturer :Fort Dodge Animal Health, Overland Park Kansas; Wyeth Laboratories, Madison, NJ
Type of Drug/Product:Heartworm treatment
FDA Release:The FDA has announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy, vomiting, seizures, difficulty walking, jaundice (a yellowish appearance), and bleeding disorders, allergies, convulsions, followed in some cases by death. ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, NADA 141-189, is an approved injectable sustained-release heartworm prevention product for dogs.
Date:May 20, 2008
Generic Name:alvimopan
Trade Name:Entereg
Manufacturer :Adolor Corp., Exton, PA; GlaxoSmithKline, London, England
Type of Drug/Product:Blocker of opioid effects in the bowel
FDA Release:The FDA has approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. FDA is approving Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.
Date:May 9, 2008
Generic Name:factor VIIa
Trade Name:NovoSeven RT
Manufacturer :Novo Nordisk A/S, Bagsværd, Denmark
Type of Drug/Product:A plasma protein essential for the clotting of blood.
FDA Release:The FDA has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years. This is helpful for health care facilities with limited refrigerated space. The original formula could be stored for three years at temperatures between 36 and 46 degrees Fahrenheit.
Date:May 9, 2008
Generic Name:ropinirole hydrochloride
Trade Name:Requip
Manufacturer :Various
Type of Drug/Product:Treatment for Restless Legs Syndrome
FDA Release:The FDA has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome. The following companies have received approval to market the generic version: Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc. Requip is also FDA-approved to treat symptoms of Parkinson's disease, but the generic products are not approved for its treatment because this indication is protected by patent.
Date:April 29, 2008
Generic Name:lubiprostone
Trade Name:Amitiza
Manufacturer :Sucampo Pharmaceuticals, Inc., Bethesda, MD
Type of Drug/Product:Treatment for Irritable Bowel Syndrome with Constipation
FDA Release:The FDA has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States. Irritable bowel syndrome is a disorder characterized by cramping, abdominal pain, bloating, constipation and diarrhea. IBS affects at least twice as many women as men.
Date:April 29, 2008
Generic Name:n/a
Trade Name:LipiScan
Manufacturer :InfraReDx Inc., Burlington, MA
Type of Drug/Product:Catheter Imaging System
FDA Release:The FDA has cleared for marketing a device that can see inside a blood vessel to assess the fat content of the plaque that builds up on the wall of the coronary arteries. The InfraReDx LipiScan NIR Catheter Imaging System uses infrared imaging to detect lipid core-containing plaques of interest and assess a patient's coronary artery lipid core burden index. The device works by placing a catheter equipped with a fiber-optic laser light into the artery.
Date:April 24, 2008
Generic Name:methylnaltrexone bromide
Trade Name:Relistor
Manufacturer :Wyeth Pharmaceuticals Inc., Philadelphia, PA; Progenics Pharmaceuticals, Inc., Tarrytown, NY
Type of Drug/Product:Treatment for Opioid-Induced Constipation
FDA Release:The FDA has approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Opioids are often prescribed on a continuous basis for patients with late-stage, advanced illness to help alleviate pain. This includes patients with a diagnosis of incurable cancer, end-stage chronic obstructive pulmonary disease (COPD) from emphysema, heart failure, Alzheimer's disease with dementia, HIV/AIDS or other advanced illnesses.
Date:April 23, 2008
Generic Name:NA
Trade Name:Yulex Patient Examination Glove
Manufacturer :Yulex Corporation, Maricopa, AZ
Type of Drug/Product:Rubber glove
FDA Release:The FDA has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States. Available data on the new guayule latex show that even people who are highly allergic to traditional latex do not react on first exposure to guayule latex proteins. Between 3 and 22 percent of all health care workers are sensitized to traditional latex.
Date:April 22, 2008
Generic Name:certolizumab pegol
Trade Name:Cimzia
Manufacturer :UCB, Inc., Smyrna, GA
Type of Drug/Product:Crohn's disease drug
FDA Release:The FDA announced the approval of Cimzia (certolizumab pegol) for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide. Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.
Date:April 21, 2008
Generic Name:NA
Trade Name:HeartMate II
Manufacturer :Thoratec Corporation, Pleasanton, CA
Type of Drug/Product:Heart assist device
FDA Release:The FDA announced the approval of a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant. The Thoratec HeartMate II Left Ventricular Assist System employs a first-of-a-kind design. Instead of the standard pulsatile pump that simulates the action of the heart, the device uses a continuous flow pump that constantly moves blood with a single moving part, a spinning rotor.
Date:April 3, 2008
Generic Name:Rotavirus vaccine
Trade Name:Rotarix
Manufacturer :GlaxoSmithKline Biologicals, Rixensart, Belgium
Type of Drug/Product:Vaccine for the prevention of rotavirus
FDA Release:The FDA announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains.
Date:March 19, 2008
Generic Name:fibrin sealant, VH S/D 4
Trade Name:Artiss
Manufacturer :Baxter Healthcare Corp., Deerfield, IL
Type of Drug/Product:Medical adhesive
FDA Release:The FDA has approved a fibrin sealant called Artiss for use in attaching skin grafts onto burn patients. Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. Artiss differs from other fibrin sealants in that it contains a lower concentration of thrombin. This lower concentration allows surgeons more time to position skin grafts over burns before the graft begins to adhere to the skin.
Date:February 28, 2008
Generic Name:esomeprazole magnesium
Trade Name:Nexium
Manufacturer :AstraZeneca PLC, Wilmington, DE
Type of Drug/Product:Treatment for gastroesophageal reflux disease (GERD).
FDA Release:The FDA has approved Nexium for short-term use in children ages 1 to 11, for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1 to 11 years old, compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.
Date:February 27, 2008
Generic Name:rilonacept
Trade Name:Arcalyst
Manufacturer :Regeneron Pharmaceuticals Inc., Tarrytown, NY
Type of Drug/Product:Treatment for two cryopyrin-associated periodic syndromes (CAPS) disorders
FDA Release:The FDA has approved Arcalyst (rilonacept, an interleukin-1 blocker) for the long-term treatment of two cryopyrin-associated periodic syndromes (CAPS) disorders: familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). Symptoms of both of these disorders include inflammation such as joint pain, rash or skin lesions, fever and chills, eye redness or pain, and fatigue in both children and adults.
Date:February 21, 2008
Generic Name:factor VIII
Trade Name:Endeavor Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free
Manufacturer :Wyeth Pharmaceuticals Inc., Philadelphia, PA
Type of Drug/Product:Treatment for hemophilia A
FDA Release:The FDA has licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals in the United States. The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients diagnosed with hemophilia A. Xyntha is also licensed to help prevent surgical bleeding in this patient population.
Date:February 7, 2008
Generic Name:decellularized heart valve
Trade Name:CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft)
Manufacturer :CryoLife Inc., Kennesaw, GA
Type of Drug/Product:Replacement heart valve
FDA Release:The FDA has cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed. Traditionally, when human tissue is recovered from a cadaver for future implantation, it is inspected, cleaned and decontaminated to prevent infection, but the allograft product remains otherwise unchanged. CryoLife Inc. has added a manufacturing step to its CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft) that decellularizes or removes the tissue's cells and cellular debris. What remains is a scaffold of connective tissue that still functions like a human heart valve, potentially lowering the risk of an immune response and subsequent tissue rejection.
Date:February 6, 2008
Generic Name:alendronate sodium
Trade Name:Fosamax
Manufacturer :Teva Pharmaceutical Industries Ltd., North Wales, PA.; Barr Laboratories, Inc., Montvale, NJ
Type of Drug/Product:Osteoporosis drug
FDA Release:The FDA has approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis. Teva Pharmaceuticals USA, North Wales, Pa., was approved to manufacture alendronate sodium tablets in three once-daily dosing strengths (5 milligrams, 10 milligrams and 40 milligrams) and two once-weekly dosing strengths (35 milligrams and 70 milligrams). Barr Laboratories, Inc., Montvale, NJ, was approved to manufacture a 70-milligram once-weekly dose of the drug.
Date:February 1, 2008
Generic Name:drug-eluting stent
Trade Name:Endeavor Zotarolimus-Eluting Coronary Stent
Manufacturer :Medtronic, Inc., Minneapolis, MN
Type of Drug/Product:Device to prevent restenosis
FDA Release:The FDA has approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart. The Endeavor is the first drug-eluting stent approved since 2004 and the first since FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents. The device is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent.
Date:January 18, 2008
Generic Name:none available
Trade Name:ProFlu
Manufacturer :Prodesse, Inc., Milwaukee, WI
Type of Drug/Product:Test to detect four common respiratory viruses
FDA Release:The FDA has cleared for marketing a test that simultaneously detects four common respiratory viruses, including the flu, in a patient's respiratory secretions. The ProFlu test provides results in as few as three hours. The real-time test allows several tests to be processed using the same sample to detect influenza A virus, influenza B virus and respiratory syncytial virus A and B (RSV).
Date:January 18, 2008
Generic Name:none available
Trade Name:Ortho Evra Contraceptive Transdermal (Skin) Patch
Manufacturer :Ortho McNeil Pharmaceuticals, Inc., Raritan, New Jersey
Type of Drug/Product:Birth control patch
FDA Release:The FDA has approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study. The study found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.
Date:January 18, 2008
Generic Name:Etravirine
Trade Name:Intelence
Manufacturer :Ortho Biotech Products, LP, Bridgewater, New Jersey
Type of Drug/Product:Non-nucleoside reverse transcriptase inhibitor (NNRTI)
FDA Release:The FDA has approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals. Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which HIV needs to multiply. The drug was approved to be used in combination with other anti-HIV medications. Sold under the trade name Intelence, etravirine received a priority review by the FDA.
Date:January 16, 2008
Generic Name:none available
Trade Name:Evicel
Manufacturer :OMRIX biopharmaceuticals LTD, Kiryat Ono, Israel
Type of Drug/Product:liquid fibrin sealant
FDA Release:The FDA expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. The sealant, called Evicel, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel's indication to include general surgery applications.
Date:January 15, 2008
Generic Name:food from animal clones
Trade Name:none available
Manufacturer :Various
Type of Drug/Product:Food
FDA Release:The FDA, after years of detailed study and analysis, has concluded that meat and milk from clones of cattle, swine and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. There was insufficient information for the agency to reach a conclusion on the safety of food from clones of other animal species, such as sheep.
Date:January 14, 2008
Generic Name:none available
Trade Name:TOP2A FISH pharmDx test
Manufacturer :Dako Denmark A/S, Glostrup, Denmark
Type of Drug/Product:Test for changes in TOP2A gene in breast cancer cells
FDA Release:The FDA has approved a test that helps in assessing the risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer. The TOP2A FISH pharmDx is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients. Changes in the TOP2A gene in breast cancer cells mean there is an increased likelihood that the tumor will recur or that long-term survival will be decreased.
Date:January 11, 2008
Generic Name:none available
Trade Name:OLYMPUS PK System Blood Group and Phenotyping Reagents
Manufacturer :DIAGAST, Loos Cedex, France
Type of Drug/Product:Blood typing tests
FDA Release:The FDA has approved 14 new tests for determining a person's blood type, a process essential to a safe U.S. blood supply and safe transfusions. Knowing the blood types for blood donors and patients is critical; patients may experience serious, possibly life-threatening reactions from mismatched transfused blood.
Date:January 3, 2008
Generic Name:Respiratory virus test
Trade Name:xTAG Respiratory Viral Panel
Manufacturer :Luminex Molecular Diagnostics, Corp., Toronto, Ontario Canada
Type of Drug/Product:Test for infectious respiratory disease viruses
FDA Release:The FDA has cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses. The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections.
Date:January 2, 2008
Generic Name:MRSA blood test
Trade Name:BD GeneOhm StaphSR test
Manufacturer :BD Diagnostics, Franklin Lakes, NJ
Type of Drug/Product:Blood test to determine presence of MRSA Staph infection
FDA Release:The FDA has announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections. The BD GeneOhm StaphSR Assay can identify whether a blood sample contains genetic material from the MRSA bacterium or the more common, less dangerous staph bacterium that can still be treated with methicillin. Test results, which used to take more than two days, can now be obtained in about two hours.

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