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Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

Hospital pharmacy

Baker DE.
PMID: 24421424
Hosp Pharm. 2013 Jan;48(1):60-7. doi: 10.1310/hpj4801-60.test.

This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions,...

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Baker DE. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals. Hosp Pharm. 2013;48(1):60-7doi: 10.1310/hpj4801-60.test.
Baker, D. E. (2013). Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals. Hospital pharmacy, 48(1), 60-7. https://doi.org/10.1310/hpj4801-60.test
Baker, Danial E. "Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals." Hospital pharmacy vol. 48,1 (2013): 60-7. doi: https://doi.org/10.1310/hpj4801-60.test
Baker DE. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals. Hosp Pharm. 2013 Jan;48(1):60-7. doi: 10.1310/hpj4801-60.test. PMID: 24421424; PMCID: PMC3839434.
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Water adsorption isotherms on porous onionlike carbonaceous particles. Simulations with the grand canonical Monte Carlo method.

The Journal of chemical physics

Hantal G, Picaud S, Hoang PN, Voloshin VP, Medvedev NN, Jedlovszky P.
PMID: 20950025
J Chem Phys. 2010 Oct 14;133(14):144702. doi: 10.1063/1.3496466.

The grand canonical Monte Carlo method is used to simulate the adsorption isotherms of water molecules on different types of model soot particles. These soot models are constructed by first removing atoms from onion-fullerene structures in order to create...

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Hantal G, Picaud S, Hoang PN, et al. Water adsorption isotherms on porous onionlike carbonaceous particles. Simulations with the grand canonical Monte Carlo method. J Chem Phys. 2010;133(14):144702doi: 10.1063/1.3496466.
Hantal, G., Picaud, S., Hoang, P. N., Voloshin, V. P., Medvedev, N. N., & Jedlovszky, P. (2010). Water adsorption isotherms on porous onionlike carbonaceous particles. Simulations with the grand canonical Monte Carlo method. The Journal of chemical physics, 133(14), 144702. https://doi.org/10.1063/1.3496466
Hantal, György, et al. "Water adsorption isotherms on porous onionlike carbonaceous particles. Simulations with the grand canonical Monte Carlo method." The Journal of chemical physics vol. 133,14 (2010): 144702. doi: https://doi.org/10.1063/1.3496466
Hantal G, Picaud S, Hoang PN, Voloshin VP, Medvedev NN, Jedlovszky P. Water adsorption isotherms on porous onionlike carbonaceous particles. Simulations with the grand canonical Monte Carlo method. J Chem Phys. 2010 Oct 14;133(14):144702. doi: 10.1063/1.3496466. PMID: 20950025.
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Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

Hospital pharmacy

Baker DE.
PMID: 24715749
Hosp Pharm. 2014 Mar;49(3):287-94. doi: 10.1310/hpj4903-287.

This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions,...

Cite
Baker DE. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals. Hosp Pharm. 2014;49(3):287-94doi: 10.1310/hpj4903-287.
Baker, D. E. (2014). Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals. Hospital pharmacy, 49(3), 287-94. https://doi.org/10.1310/hpj4903-287
Baker, Danial E. "Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals." Hospital pharmacy vol. 49,3 (2014): 287-94. doi: https://doi.org/10.1310/hpj4903-287
Baker DE. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals. Hosp Pharm. 2014 Mar;49(3):287-94. doi: 10.1310/hpj4903-287. PMID: 24715749; PMCID: PMC3971115.
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The case for HER2/neu as a therapeutic target for gynecologic malignancies.

Immunotherapy

Goyne HE, Cannon MJ.
PMID: 22947006
Immunotherapy. 2012 Aug;4(8):781-4. doi: 10.2217/imt.12.71.

Evaluation of: Guzzo F, Bellone S, Buza N et al. HER2/neu as a potential target for immunotherapy in gynecological carcinosarcomas. Int. J. Gynecol. Pathol. 31, 211-221 (2012). Trastuzumab (Herceptin(®)) is a human monoclonal antibody that is US FDA-approved for...

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Goyne HE, Cannon MJ. The case for HER2/neu as a therapeutic target for gynecologic malignancies. Immunotherapy. 2012;4(8):781-4doi: 10.2217/imt.12.71.
Goyne, H. E., & Cannon, M. J. (2012). The case for HER2/neu as a therapeutic target for gynecologic malignancies. Immunotherapy, 4(8), 781-4. https://doi.org/10.2217/imt.12.71
Goyne, Hannah E, and Cannon, Martin J. "The case for HER2/neu as a therapeutic target for gynecologic malignancies." Immunotherapy vol. 4,8 (2012): 781-4. doi: https://doi.org/10.2217/imt.12.71
Goyne HE, Cannon MJ. The case for HER2/neu as a therapeutic target for gynecologic malignancies. Immunotherapy. 2012 Aug;4(8):781-4. doi: 10.2217/imt.12.71. PMID: 22947006.
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Pre-service ultrasonic and manual evaluation of the reproductive organs of dairy cows presumed to be in estrus.

SpringerPlus

Hansar E, Lemma A, Yilma T.
PMID: 25279320
Springerplus. 2014 Sep 15;3:529. doi: 10.1186/2193-1801-3-529. eCollection 2014.

Manual and ultrasonic evaluation of the the reproductive organs of 62 dairy cows and heifers belonging to smallholder farms was conducted. The objective was to assess the efficiency of visual estrus detection method in the dairy animals that were...

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Hansar E, Lemma A, Yilma T. Pre-service ultrasonic and manual evaluation of the reproductive organs of dairy cows presumed to be in estrus. Springerplus. 2014;3:529doi: 10.1186/2193-1801-3-529.
Hansar, E., Lemma, A., & Yilma, T. (2014). Pre-service ultrasonic and manual evaluation of the reproductive organs of dairy cows presumed to be in estrus. SpringerPlus, 3529. https://doi.org/10.1186/2193-1801-3-529
Hansar, Endris, et al. "Pre-service ultrasonic and manual evaluation of the reproductive organs of dairy cows presumed to be in estrus." SpringerPlus vol. 3 (2014): 529. doi: https://doi.org/10.1186/2193-1801-3-529
Hansar E, Lemma A, Yilma T. Pre-service ultrasonic and manual evaluation of the reproductive organs of dairy cows presumed to be in estrus. Springerplus. 2014 Sep 15;3:529. doi: 10.1186/2193-1801-3-529. eCollection 2014. PMID: 25279320; PMCID: PMC4171461.
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Infinitely Adaptive Transition-Metal Ordering in Ln2O2MSe2-Type Oxychalcogenides.

Inorganic chemistry

Ainsworth CM, Wang CH, Johnston HE, McCabe EE, Tucker MG, Brand HE, Evans JS.
PMID: 25924673
Inorg Chem. 2015 Aug 03;54(15):7230-8. doi: 10.1021/acs.inorgchem.5b00599. Epub 2015 Apr 30.

A number of Ln2O2MSe2 (Ln = La and Ce; M = Fe, Zn, Mn, and Cd) compounds, built from alternating layers of fluorite-like [Ln2O2](2+) sheets and antifluorite-like [MSe2](2-) sheets, have recently been reported in the literatures. The available MSe4/2...

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Ainsworth CM, Wang CH, Johnston HE, et al. Infinitely Adaptive Transition-Metal Ordering in Ln2O2MSe2-Type Oxychalcogenides. Inorg Chem. 2015;54(15):7230-8doi: 10.1021/acs.inorgchem.5b00599.
Ainsworth, C. M., Wang, C. H., Johnston, H. E., McCabe, E. E., Tucker, M. G., Brand, H. E., & Evans, J. S. (2015). Infinitely Adaptive Transition-Metal Ordering in Ln2O2MSe2-Type Oxychalcogenides. Inorganic chemistry, 54(15), 7230-8. https://doi.org/10.1021/acs.inorgchem.5b00599
Ainsworth, Chris M, et al. "Infinitely Adaptive Transition-Metal Ordering in Ln2O2MSe2-Type Oxychalcogenides." Inorganic chemistry vol. 54,15 (2015): 7230-8. doi: https://doi.org/10.1021/acs.inorgchem.5b00599
Ainsworth CM, Wang CH, Johnston HE, McCabe EE, Tucker MG, Brand HE, Evans JS. Infinitely Adaptive Transition-Metal Ordering in Ln2O2MSe2-Type Oxychalcogenides. Inorg Chem. 2015 Aug 03;54(15):7230-8. doi: 10.1021/acs.inorgchem.5b00599. Epub 2015 Apr 30. PMID: 25924673.
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Author Correction: CHD3 helicase domain mutations cause a neurodevelopmental syndrome with macrocephaly and impaired speech and language.

Nature communications

Blok LS, Rousseau J, Twist J, Ehresmann S, Takaku M, Venselaar H, Rodan LH, Nowak CB, Douglas J, Swoboda KJ, Steeves MA, Sahai I, Stumpel CTRM, Stegmann APA, Wheeler P, Willing M, Fiala E, Kochhar A, Gibson WT, Cohen ASA, Agbahovbe R, Innes AM, Au PYB, Rankin J, Anderson IJ, Skinner SA, Louie RJ, Warren HE, Afenjar A, Keren B, Nava C, Buratti J, Isapof A, Rodriguez D, Lewandowski R, Propst J, van Essen T, Choi M, Lee S, Chae JH, Price S, Schnur RE, Douglas G, Wentzensen IM, Zweier C, Reis A, Bialer MG, Moore C, Koopmans M, Brilstra EH, Monroe GR, van Gassen KLI, van Binsbergen E, Newbury-Ecob R, Bownass L, Bader I, Mayr JA, Wortmann SB, Jakielski KJ, Strand EA, Kloth K, Bierhals T, Roberts JD, Petrovich RM, Machida S, Kurumizaka H, Lelieveld S, Pfundt R, Jansen S, Deriziotis P, Faivre L, Thevenon J, Assoum M, Shriberg L, Kleefstra T, Brunner HG, Wade PA, Fisher SE, Campeau PM.
PMID: 30770872
Nat Commun. 2019 Feb 15;10(1):883. doi: 10.1038/s41467-019-08800-2.

The original version of this Article contained an error in the spelling of the author Laurence Faivre, which was incorrectly given as Laurence Faive. This has now been corrected in both the PDF and HTML versions of the Article.

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Blok LS, Rousseau J, Twist J, et al. Author Correction: CHD3 helicase domain mutations cause a neurodevelopmental syndrome with macrocephaly and impaired speech and language. Nat Commun. 2019;10(1):883doi: 10.1038/s41467-019-08800-2.
Blok, L. S., Rousseau, J., Twist, J., Ehresmann, S., Takaku, M., Venselaar, H., Rodan, L. H., Nowak, C. B., Douglas, J., Swoboda, K. J., Steeves, M. A., Sahai, I., Stumpel, C. T. R. M., Stegmann, A. P. A., Wheeler, P., Willing, M., Fiala, E., Kochhar, A., Gibson, W. T., Cohen, A. S. A., Agbahovbe, R., Innes, A. M., Au, P. Y. B., Rankin, J., Anderson, I. J., Skinner, S. A., Louie, R. J., Warren, H. E., Afenjar, A., Keren, B., Nava, C., Buratti, J., Isapof, A., Rodriguez, D., Lewandowski, R., Propst, J., van Essen, T., Choi, M., Lee, S., Chae, J. H., Price, S., Schnur, R. E., Douglas, G., Wentzensen, I. M., Zweier, C., Reis, A., Bialer, M. G., Moore, C., Koopmans, M., Brilstra, E. H., Monroe, G. R., van Gassen, K. L. I., van Binsbergen, E., Newbury-Ecob, R., Bownass, L., Bader, I., Mayr, J. A., Wortmann, S. B., Jakielski, K. J., Strand, E. A., Kloth, K., Bierhals, T., Roberts, J. D., Petrovich, R. M., Machida, S., Kurumizaka, H., Lelieveld, S., Pfundt, R., Jansen, S., Deriziotis, P., Faivre, L., Thevenon, J., Assoum, M., Shriberg, L., Kleefstra, T., Brunner, H. G., Wade, P. A., Fisher, S. E., & Campeau, P. M. (2019). Author Correction: CHD3 helicase domain mutations cause a neurodevelopmental syndrome with macrocephaly and impaired speech and language. Nature communications, 10(1), 883. https://doi.org/10.1038/s41467-019-08800-2
Blok, Lot Snijders, et al. "Author Correction: CHD3 helicase domain mutations cause a neurodevelopmental syndrome with macrocephaly and impaired speech and language." Nature communications vol. 10,1 (2019): 883. doi: https://doi.org/10.1038/s41467-019-08800-2
Blok LS, Rousseau J, Twist J, Ehresmann S, Takaku M, Venselaar H, Rodan LH, Nowak CB, Douglas J, Swoboda KJ, Steeves MA, Sahai I, Stumpel CTRM, Stegmann APA, Wheeler P, Willing M, Fiala E, Kochhar A, Gibson WT, Cohen ASA, Agbahovbe R, Innes AM, Au PYB, Rankin J, Anderson IJ, Skinner SA, Louie RJ, Warren HE, Afenjar A, Keren B, Nava C, Buratti J, Isapof A, Rodriguez D, Lewandowski R, Propst J, van Essen T, Choi M, Lee S, Chae JH, Price S, Schnur RE, Douglas G, Wentzensen IM, Zweier C, Reis A, Bialer MG, Moore C, Koopmans M, Brilstra EH, Monroe GR, van Gassen KLI, van Binsbergen E, Newbury-Ecob R, Bownass L, Bader I, Mayr JA, Wortmann SB, Jakielski KJ, Strand EA, Kloth K, Bierhals T, Roberts JD, Petrovich RM, Machida S, Kurumizaka H, Lelieveld S, Pfundt R, Jansen S, Deriziotis P, Faivre L, Thevenon J, Assoum M, Shriberg L, Kleefstra T, Brunner HG, Wade PA, Fisher SE, Campeau PM. Author Correction: CHD3 helicase domain mutations cause a neurodevelopmental syndrome with macrocephaly and impaired speech and language. Nat Commun. 2019 Feb 15;10(1):883. doi: 10.1038/s41467-019-08800-2. PMID: 30770872; PMCID: PMC6377600.
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Sex-associated differences in excitability within the bed nucleus of the stria terminalis are reflective of cell-type.

Neurobiology of stress

Smithers HE, Terry JR, Brown JT, Randall AD.
PMID: 30937349
Neurobiol Stress. 2018 Dec 19;10:100143. doi: 10.1016/j.ynstr.2018.100143. eCollection 2019 Feb.

The bed nucleus of the stria terminalis (BNST) is a sexually dimorphic brain region which plays a key role in stress, anxiety, and anxiety-related disorders. Human females have an increased susceptibility to anxiety-related disorders, however the physiological basis of...

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Smithers HE, Terry JR, Brown JT, et al. Sex-associated differences in excitability within the bed nucleus of the stria terminalis are reflective of cell-type. Neurobiol Stress. 2018;10:100143doi: 10.1016/j.ynstr.2018.100143.
Smithers, H. E., Terry, J. R., Brown, J. T., & Randall, A. D. (2019). Sex-associated differences in excitability within the bed nucleus of the stria terminalis are reflective of cell-type. Neurobiology of stress, 10100143. https://doi.org/10.1016/j.ynstr.2018.100143
Smithers, Hannah E, et al. "Sex-associated differences in excitability within the bed nucleus of the stria terminalis are reflective of cell-type." Neurobiology of stress vol. 10 (2019): 100143. doi: https://doi.org/10.1016/j.ynstr.2018.100143
Smithers HE, Terry JR, Brown JT, Randall AD. Sex-associated differences in excitability within the bed nucleus of the stria terminalis are reflective of cell-type. Neurobiol Stress. 2018 Dec 19;10:100143. doi: 10.1016/j.ynstr.2018.100143. eCollection 2019 Feb. PMID: 30937349; PMCID: PMC6430407.
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Two unrelated patients with autosomal dominant omodysplasia and .

Clinical case reports

Warren HE, Louie RJ, Friez MJ, Frías JL, Leroy JG, Spranger JW, Skinner SA, Champaigne NL.
PMID: 30455931
Clin Case Rep. 2018 Oct 15;6(11):2252-2255. doi: 10.1002/ccr3.1818. eCollection 2018 Nov.

Presented are two patients with autosomal dominant omodysplasia and mutations in the

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Warren HE, Louie RJ, Friez MJ, et al. Two unrelated patients with autosomal dominant omodysplasia and . Clin Case Rep. 2018;6(11):2252-2255doi: 10.1002/ccr3.1818.
Warren, H. E., Louie, R. J., Friez, M. J., Frías, J. L., Leroy, J. G., Spranger, J. W., Skinner, S. A., & Champaigne, N. L. (2018). Two unrelated patients with autosomal dominant omodysplasia and . Clinical case reports, 6(11), 2252-2255. https://doi.org/10.1002/ccr3.1818
Warren, Hannah E, et al. "Two unrelated patients with autosomal dominant omodysplasia and ." Clinical case reports vol. 6,11 (2018): 2252-2255. doi: https://doi.org/10.1002/ccr3.1818
Warren HE, Louie RJ, Friez MJ, Frías JL, Leroy JG, Spranger JW, Skinner SA, Champaigne NL. Two unrelated patients with autosomal dominant omodysplasia and . Clin Case Rep. 2018 Oct 15;6(11):2252-2255. doi: 10.1002/ccr3.1818. eCollection 2018 Nov. PMID: 30455931; PMCID: PMC6230601.
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Social-ecological landscape patterns predict woody encroachment from native tree plantings in a temperate grassland.

Ecology and evolution

Donovan VM, Burnett JL, Bielski CH, Birgé HE, Bevans R, Twidwell D, Allen CR.
PMID: 30386562
Ecol Evol. 2018 Sep 05;8(19):9624-9632. doi: 10.1002/ece3.4340. eCollection 2018 Oct.

Afforestation is often viewed as the purposeful planting of trees in historically nonforested grasslands, but an unintended consequence is woody encroachment, which should be considered part of the afforestation process. In North America's temperate grassland biome, Eastern redcedar (

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Donovan VM, Burnett JL, Bielski CH, et al. Social-ecological landscape patterns predict woody encroachment from native tree plantings in a temperate grassland. Ecol Evol. 2018;8(19):9624-9632doi: 10.1002/ece3.4340.
Donovan, V. M., Burnett, J. L., Bielski, C. H., Birgé, H. E., Bevans, R., Twidwell, D., & Allen, C. R. (2018). Social-ecological landscape patterns predict woody encroachment from native tree plantings in a temperate grassland. Ecology and evolution, 8(19), 9624-9632. https://doi.org/10.1002/ece3.4340
Donovan, Victoria M, et al. "Social-ecological landscape patterns predict woody encroachment from native tree plantings in a temperate grassland." Ecology and evolution vol. 8,19 (2018): 9624-9632. doi: https://doi.org/10.1002/ece3.4340
Donovan VM, Burnett JL, Bielski CH, Birgé HE, Bevans R, Twidwell D, Allen CR. Social-ecological landscape patterns predict woody encroachment from native tree plantings in a temperate grassland. Ecol Evol. 2018 Sep 05;8(19):9624-9632. doi: 10.1002/ece3.4340. eCollection 2018 Oct. PMID: 30386562; PMCID: PMC6202738.
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Impairment in delay discounting in schizophrenia and schizoaffective disorder but not primary mood disorders.

NPJ schizophrenia

Brown HE, Hart KL, Snapper LA, Roffman JL, Perlis RH.
PMID: 29808011
NPJ Schizophr. 2018 May 28;4(1):9. doi: 10.1038/s41537-018-0050-z.

A measure of planning and impulse control, the delay-discounting (DD) task estimates the extent to which an individual decreases the perceived value of a reward as the reward is delayed. We examined cross-disorder performance between healthy controls (n =...

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Brown HE, Hart KL, Snapper LA, et al. Impairment in delay discounting in schizophrenia and schizoaffective disorder but not primary mood disorders. NPJ Schizophr. 2018;4(1):9doi: 10.1038/s41537-018-0050-z.
Brown, H. E., Hart, K. L., Snapper, L. A., Roffman, J. L., & Perlis, R. H. (2018). Impairment in delay discounting in schizophrenia and schizoaffective disorder but not primary mood disorders. NPJ schizophrenia, 4(1), 9. https://doi.org/10.1038/s41537-018-0050-z
Brown, Hannah E, et al. "Impairment in delay discounting in schizophrenia and schizoaffective disorder but not primary mood disorders." NPJ schizophrenia vol. 4,1 (2018): 9. doi: https://doi.org/10.1038/s41537-018-0050-z
Brown HE, Hart KL, Snapper LA, Roffman JL, Perlis RH. Impairment in delay discounting in schizophrenia and schizoaffective disorder but not primary mood disorders. NPJ Schizophr. 2018 May 28;4(1):9. doi: 10.1038/s41537-018-0050-z. PMID: 29808011; PMCID: PMC5972152.
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Riders in the sky (islands): using a mega-phylogenetic approach to understand plant species distribution and coexistence at the altitudinal limits of angiosperm plant life.

Journal of biogeography

Marx HE, Dentant C, Renaud J, Delunel R, Tank DC, Lavergne S.
PMID: 29249850
J Biogeogr. 2017 Nov;44(11):2618-2630. doi: 10.1111/jbi.13073. Epub 2017 Aug 04.

AIM: Plants occurring on high-alpine summits are generally expected to persist due to adaptations to extreme selective forces caused by the harshest climates where angiosperm life is known to thrive. We assessed the relative effects of this strong environmental...

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Marx HE, Dentant C, Renaud J, et al. Riders in the sky (islands): using a mega-phylogenetic approach to understand plant species distribution and coexistence at the altitudinal limits of angiosperm plant life. J Biogeogr. 2017;44(11):2618-2630doi: 10.1111/jbi.13073.
Marx, H. E., Dentant, C., Renaud, J., Delunel, R., Tank, D. C., & Lavergne, S. (2017). Riders in the sky (islands): using a mega-phylogenetic approach to understand plant species distribution and coexistence at the altitudinal limits of angiosperm plant life. Journal of biogeography, 44(11), 2618-2630. https://doi.org/10.1111/jbi.13073
Marx, Hannah E, et al. "Riders in the sky (islands): using a mega-phylogenetic approach to understand plant species distribution and coexistence at the altitudinal limits of angiosperm plant life." Journal of biogeography vol. 44,11 (2017): 2618-2630. doi: https://doi.org/10.1111/jbi.13073
Marx HE, Dentant C, Renaud J, Delunel R, Tank DC, Lavergne S. Riders in the sky (islands): using a mega-phylogenetic approach to understand plant species distribution and coexistence at the altitudinal limits of angiosperm plant life. J Biogeogr. 2017 Nov;44(11):2618-2630. doi: 10.1111/jbi.13073. Epub 2017 Aug 04. PMID: 29249850; PMCID: PMC5730081.
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