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Chart lists efficacy supplements and labeling supplements selected by the editors of "Pharmaceutical Approvals Monthly." This is not a comprehensive list of all supplemental approvals
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Drug
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Aplenzin
Bupropion
Valeant
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Eliminates REMS requirement while retaining MedGuide; adds new safety information to be included in the labeling for bupropion products pertaining to the risk of suicidality-related events in patients using it for smoking cessation
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4/29/2011
(22-108/002 & 003)
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Chorionic gonadotropin
APP
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Adds warning to be included in labeling for all urinary-derived human chorionic gonadotropin products that anaphylaxis and other hypersensitivity reactions have been reported
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4/15/2011
(17-067/057)
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Eligard
Leuprolide
Sanofi-Aventis
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Clarifies warning that increased risk of myocardial infarction, sudden cardiac death and stroke has been reported to specify "in men"
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4/8/2011
(21-343/020)
(21-379/016)
(21-488/017)
(21-731/013)
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Fosrenol
Lanthanum
Shire
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Adds new section regarding gastrointestinal adverse effects to warnings, noting serious cases of gastrointestinal obstruction, ileus and fecal impaction have been reported, some requiring surgery
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4/27/2011
(21-468/014 & 015)
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Fuzilev
Levoleucovorin
Spectrum
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Adds use in combination chemotherapy with 5-fluorouracil for the palliative treatment of patients with advanced metastatic colorectal cancer
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4/29/2011
(20-140/002)
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Fuzeon
Enfuvirtide
Roche
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Updates warnings regarding pneumonia with information from an observational study in 1,850 HIV-infected patients showing the incidence of pneumonia was 3.2/100 patient-years with Fuzeon compared to 1.8/100 in the non-Fuzeon arm and concluding it is not possible to exclude an increased risk in patients treated with Fuzeon
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4/28/2011
(21-481/020)
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Gleevec
Imatinib
Novartis
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Converts accelerated approval into full approval with final clinical data from a trial in newly diagnosed pediatric Philadelphia+ chronic myelogenous leukemia
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4/1/2011
(21-588/030 & 031)
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Invega
Paliperidone
Ortho McNeil Janssen
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Adds indication for treatment of schizophrenia in adolescents 12 to 17 years of age; relocates the descriptive summary of experience with weight gain from the adverse reactions section to warnings and precautions and in the highlights section
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4/6/2011
(21-999/020 & 024)
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Janumet
Metformin/sitagliptin
Merck
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Eliminates REMS; adds information regarding postmarketing reports of worsening renal function, including acute renal failure (sometimes requiring dialysis) to labeling and MedGuide
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4/14/2011
(22-044/016)
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Januvia
Sitagliptin
Merck
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Eliminates REMS; adds information regarding postmarketing reports of worsening renal function, including acute renal failure (sometimes requiring dialysis) to labeling and MedGuide
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4/14/2011
(21-995/017)
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Lamictal XR
Lamotrigine
GlaxoSmithKline
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Alters patient population to include monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug; eliminates REMS
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4/25/2011
(22-115/006)
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Lyrica
Pregabalin
Pfizer
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Eliminates REMS and makes changes to the MedGuide
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4/26/2011
(22-488/023, 024, 001 & 003)
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Lysteda
Tranexamic acid
Ferring
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Revises warnings on risk of thromboembolic events, particularly in women who are obese or smoke cigarettes and are using both Lysteda and a hormonal contraceptive; adds new language that it should not be used in women taking more than the approved dose of a hormonal contraceptive
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4/6/2011
(22-430/002)
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Naglazyme
Galsulfase
BioMarin
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Adds to warnings and precautions that anaphylaxis and severe allergic reactions have been observed in patients during and up to 24 hours after infusion; that type III immune complex-mediated reactions, including membranous glomerulonephritis have been observed, as with other enzyme replacement therapies; and that caution should be exercised with patients susceptible to fluid volume overload, such as patients weighing 20 kg or less, patients with acute underlying respiratory illness or patients with compromised cardiac and/or respiratory function, because congestive heart failure may result
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4/28/2011
(125-117/086, 088 & 090)
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Novarel
Chorionic gonadotropin
Ferring
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Adds warning to be included in labeling for all urinary-derived human chorionic gonadotropin products that anaphylaxis and other hypersensitivity reactions have been reported
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4/15/2011
(17-016/156)
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Omnitrope
Somatropin, recombinant
Sandoz
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Adds to warnings a section on pancreatitis noting that cases have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults; published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children
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4/13/2011
(21-426/018)
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Pradaxa
Dabigatran
Boehringer Ingelheim
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Eliminates REMS
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4/5/2011
(22-512/005)
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Pregnyl
Chorionic gonadotropin
Organon
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Adds warning to be included in labeling for all urinary-derived human chorionic gonadotropin products that anaphylaxis and other hypersensitivity reactions have been reported
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4/15/2011
(17-692/021)
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Pristiq
Desvenlafaxine
Wyeth
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Modifies MedGuide to reflect important information concerning vertigo, adding "feeling that your surroundings are moving" to common side effects
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4/11/2011
(21-992/022)
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Propecia
Finasteride
Merck
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Includes male breast cancer in the adverse reactions/postmarketing experience section
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4/13/2011
(20-788/018)
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Prozac
Fluoxetine
Lilly
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Adds a statement to specific populations: pregnancy section regarding the potential risk of cardiovascular defects in infants of women who were exposed during the first trimester of pregnancy; provides for a comprehensive MedGuide
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4/4/2011
(18-936/093 & 095)
(21-235/016 & 017)
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Sarafem
Fluoxetine
Lilly
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Adds a statement to specific populations: pregnancy section regarding the potential risk of cardiovascular defects in infants of women who were exposed during the first trimester of pregnancy; provides for a comprehensive MedGuide
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4/4/2011
(18-936/093 & 095)
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Symbyax
Fluoxetine/olanzapine
Lilly
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Under special populations: pregnancy, adds a warning that it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; adds that there are no adequate and well-controlled clinical studies on use in pregnant women and that, while more than 10 cohort and case-control studies failed to demonstrate an increased risk for congenital malformations overall, one prospective cohort study reported an increased risk of cardiovascular malformations in infants born to women exposed during the first trimester compared to those who weren't
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4/22/2011
(21-520/025)
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Votrient
Pazopanib
GlaxoSmithKline
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Eliminates REMS requirement, including the MedGuide
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4/21/2011
(22-465/006)
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Biologic
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Actemra
Tocilizumab
Genentech
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New indication as monotherapy or in combination with methotrexate for treatment of active systemic juvenile idiopathic arthritis in children 2 years of age and older
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4/15/2011
(125276/0022 & 0023)
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Rituxan
Rituximab
Genentech
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Adds new indication for use in combination with glucocorticoids for treatment of patients with Wegner's granulomatosis and microscopic polyangiitis
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4/19/2011
(103705/5344)
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Tysabri
Natalizumab
Biogen
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Updates warning on progressive multifocal leukoencephalopathy to add a table summarizing cases according to the number of infusions received; adds that patients treated with immune suppressing medications prior to taking natalizumab are at increased risk for PML infection
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4/1/2011
(125104/438 & 475)
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