October 2009

  • FDA has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain hospitalised adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection.
  • Virilization has been reported in children who were secondarily exposed to testosterone gel in postmarket surveillance.
  • Rapamune (Sirolimus) has been associated with adverse outcomes in patients following liver transplantation, including excess mortality, graft loss and Hepatic Artery Thrombosis (HAT); therefore, such use is not recommended.
  • FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use (3 to 17 yrs).
  • Votrient (pazopanib), an oral medication that interferes with angiogenesis, is the sixth drug to be approved by FDA for kidney cancer since 2005.
  • Progressive multifocal leukoencephalopathy [PML], has been reported in a patient with rheumatoid arthritis [RA] treated with Rituxan (Rituximab) who has not previously received treatment with a TNF antagonist.
  • The FDA has approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by HPV types 16 and 18, for use in girls and women ages 10 years through 25 years.
  • The Boxed Warning of Dexferrum (iron dextran injection) has been modified by FDA to recommend administering a test dose prior to the first therapeutic dose.
  • Berinert (a protein product derived from human plasma), the first treatment for acute abdominal attacks and facial swelling associated with hereditary angioedema (HAE) has got FDA approval.
  • In a recent trial, low-dose danazol tablets placed in the vagina were safe and effective in reducing menorrhagia in young fertile women and promoted no significant adverse effects.
  • GlaxoSmithKline withdraws its marketing authorisation application from EMEA for Zunrisa (casopitant mesilate), drug to be used in the prevention of post-operative and chemotherapy-induced nausea and vomiting.
  • Now heparin in the U.S. will be about 10% less potent, unit for unit, than it is today after USP changed standards.
  • Prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.
  • The DCGI office has decided to implement WHO certification scheme by CDSCO from 1st October 2009 and now COPPs will be issued by office of CDSCO after inspection.
  • Pralatrexate for the treatment of relapsed or refractory peripheral T-cell lymphoma has been approved by US FDA
  • SOHM, Inc., announced the launch of 26 branded generic pharmaceutical products in India.
  • New FDA Risk Evaluation & Mitigation Strategies (REMS) draft guidance is open for assessment by Pharma and biotech companies.

November 2009

  • FDA panel has recommended Prevnar 13 pneumococcal vaccine, composed of capsular polysaccharides from the 13 pneumococcal serotypes, for approval against active immunization of children with serious systemic infection.
  • The USFDA has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).
  • New European AIDS Clinical Society (EACS) guidelines recommend that clinicians begin treatment of HIV-positive patients earlier, when CD4 cell counts are 350 to 500 cells/mL, to improve long-term outcomes and minimize comorbidities.
  • FDA has received reports of six deaths and 77 injuries associated with Negative Pressure Wound Therapy (NPWT) systems over the past two years and has issued a Preliminary Public Health Notification.
  • FDA granted tentative approval for a generic formulation of fixed dose combination lopinavir/ritonavir tablets, 200 mg/50 mg, made by Cipla Limited, India.

December 2009

  • Endo, Novartis and FDA has added new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium (even topical gel) to the Prescribing Information.
  • GSK has added myocardial infarction and hypercholesterolemia to the Adverse Reactions section of the LEXIVA (fosamprenavir calcium) Tablets and Oral Suspension Prescribing Information.
  • The USFDA has approved Kalbitor (ecallantide) to treat sudden and potentially life-threatening fluid buildup that can occur in people with hereditary angioedema.
  • The new safety information of Norpramin (desipramine hydrochloride) states that extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances.
  • The recently (Dec 1, 2009) revised FDA guidelines for the use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents recommends earlier initiation of antiretroviral therapy (even for CD4 counts >500 cells/mm3) and have also included a new section entitled “Considerations in Managing Patients with HIV-2 Infection”.
  • The USFDA has approved Agriflu vaccine for people aged 18 years and older to prevent disease caused by influenza virus subtypes A and B.

January 2010

  • FDA Approves SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) for the Reduction of COPD Exacerbations, which was earlier approved as a once-daily maintenance treatment for breathing problems associated with COPD.
  • The Phase I trial of ADXS11-001, the live attenuated Listeria monocytogenes (Lm) vaccine by Advaxis Inc., has shown thirty-six (36) month survival in two of the thirteen evaluable patients with cervical cancer.
  • Amid recurring allegations of medical negligence and reports that many aspects of medical practices are error-prone, the Indian Health Ministry has launched a pilot project to ensure patient safety by setting up specially assigned panels in hospitals to monitor preventable errors.
  • An NIH-funded study has successfully demonstrated use of cocaine vaccine for treating addiction.
  • Novexel, a speciality pharmaceutical company focused on the discovery and development of novel antibiotics, shall be Acquired by AstraZeneca by Q1 2010.

Febuary 2010

  • The Central Drugs Standard Control Organization, India has issued a set of new rules (17 points) to be strictly followed by the pharma exporters in the country while doing international trade effective from January 1, 2010.
  • The USFDA has approved Victoza (liraglutide), a once-daily GLP-1 receptor agonist, injection to treat type 2 diabetes in some adults. It should be used with caution in people with a history of pancreatitis.
  • Ampyra (dalfampridine) extended release tablets has got USFDA approval to improve walking in patients with multiple sclerosis (MS).
  • Church & Dwight, Co., Inc. announced that the USFDA has cleared the First Response Early Result Pregnancy Test which can determine pregnancy up to six days before the day of a woman’s missed period.
  • FDA notified healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine), a medication used to treat human immunodeficiency virus (HIV) infection.
  • The USFDA has approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart.

April 2010

  • USFDA has approved TachoSil, the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels, when standard surgical techniques are ineffective or impractical.
  • Asclera (polidocanol) injection has been approved recently by USFDA for the treatment of spider (< 1 mm diameter) and reticular (1 to 3 mm diameter) types of varicose veins.
  • Xifaxan (rifaximin), a drug that has been approved for the treatment of traveler’s diarrhea has now been approved for reducing levels of ammonia in the blood in patients with hepatic encephalopathy by USFDA.
  • The FDA has warned patients and healthcare providers about the potential for increased risk of muscle injury from high dose Zocor (simvastatin) 80 mg.
  • Botox (onabotulinumtoxin A) has now been approved in US for treatment of spasticity in the flexor muscles of the elbow, wrist, and fingers in adults commonly seen after stroke, traumatic brain injury, or the progression of multiple sclerosis.
  • Tykerb (lapatinib) tablets has got accelerated approval for use in combination with letrozole tablets to treat postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor.
  • The USFDA has approved velaglucerase alfa injection (VPRIV) to treat children and adults with Gaucher disease, a rare genetic disorder.

July 2010

  • The USFDA has recently approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer, Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML).
  • Jevtana (cabazitaxel), has been a first chemotherapy to get approval for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel.
  • USFDA has approved the Implantable Miniature Telescope (IMT) to improve vision in patients with end-stage age-related macular degeneration (AMD).
  • Mylotarg (gemtuzumab ozogamicin), approved in May 2000 under the FDA’s accelerated approval program for treatment of acute myeloid leukemia (AML), has been withdrawn as trials showed no improvement in clinical benefit, and greater number of deaths occurred in the group receiving Mylotarg compared with those receiving chemotherapy alone.
  • Cuvposa (glycopyrrolate) oral Solution has been approved by USFDA to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.
  • Treatment with Cubicin (daptomycin), an intravenous antibacterial drug, first approved in September 2003, has the potential for developing eosinophilic pneumonia.

September 2010

  • The USFDA has approved Krystexxa (pegloticase) to treat gout in adults who do not respond to or who cannot tolerate conventional therapy.
  • Gadolinium-based contrast agents (GBCAs) will now carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF), if the drug is administered to certain patients with kidney disease.
  • USFDA has approved the pediatric use of IV or IM injection of Protopam Chloride (pralidoxime chloride), to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents).
  • The USFDA has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS).
  • FDA has notified healthcare professionals and patients that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications.
  • Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg) has been approved by USFDA for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

November 2010

  • The FDA has approved Cymbalta (duloxetine hydrochloride), a drug earlier approved for major depressive disorder, to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.
  • Cancer drug Afinitor (everolimus) to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), a rare genetic disorder, has got recent FDA approval.
  • Teflaro (ceftaroline fosamil), an injectable antibiotic, is now approved to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).
  • The FDA has approved a new indication for Sprycel (dasatinib) for the treatment of Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), a slowly progressing blood and bone marrow disease linked to a genetic abnormality.
  • Latuda (lurasidone HCl) tablets have now been approved by USFDA for the treatment of adults with schizophrenia. Latuda is included in the atypical antipsychotic class of drugs.
  • Egrifta, the first FDA-approved treatment for lipodystrophy, is a synthetic growth hormone releasing factor (GRF) drug that is administered in a once-daily injection. Egrifta was approved to induce and maintain a reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy.
  • USFDA is informing healthcare professionals and patients that the drug Lamictal (lamotrigine) can cause aseptic meningitis. Lamictal is approved to treat bipolar disorder in adults, and seizures in adults and children two years and older.
  • New risk information has been added to the label of the antiviral drug Invirase (saquinavir), describing a potential change in the electrical activity of the heart when Invirase is used in combination with Norvir (ritonavir), leading to abnormal heart rhythms.
  • Pradaxa capsules (dabigatran etexilate), approved by FDA can now be given for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).
  • Botox injection (onabotulinumtoxinA) has got FDA approval for prevention of headaches in adult patients with chronic migraine.
  • The possible risk warning of atypical thigh bone (femoral) fracture in patients treated with bisphosphonates, a class of drugs used to prevent and treat osteoporosis has been issued requiring labeling change.

March 2011

  • An ongoing safety review of Recombinant Human Growth Hormone administration during childhood found a small increased risk of death over a long period of time, compared to individuals in the general population of France.
  • FDA has recently approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer.
  • Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients.
  • Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of anaplastic large cell lymphoma (ALCL) in the scar capsule adjacent to the implant.
  • Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency, has been approved by USFDA.
  • Edarbi tablets (azilsartan medoxomil) have been recently approved to treat high blood pressure (hypertension) in adults.
  • USFDA has approved roflumilast to decrease the frequency of flare-ups or worsening of symptoms from severe COPD.
  • New data suggest that Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy.
  • FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis (ambrisentan), conveying that monthly liver enzyme tests are no longer required.