The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement.
PTI
December 26, 2022 / 11:07 AM IST
Pharma
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stockWidget(‘N’,stkId,articleId); }); $ (‘#stk-b-‘+articleId).click(function(){ stkId = jQuery.trim($ (this).attr(‘stkId’)); stockWidget(‘B’,stkId,articleId); $ (‘.bselivelist’).hide(); }); $ (‘#stk-n-‘+articleId).click(function(){ stkId = jQuery.trim($ (this).attr(‘stkId’)); stockWidget(‘N’,stkId,articleId); $ (‘.bselivelist’).hide(); }); } $ (“.bselivelist”).focusout(function(){ $ (“.bselivelist”).hide(); //hide the results }); function bindMenuClicks(articleId){ $ (‘#watchlist-‘+articleId).click(function(){ var stkId = $ (this).attr(‘stkId’); overlayPopupWatchlist(0,2,1,stkId); }); $ (‘#portfolio-‘+articleId).click(function(){ var dispId = $ (this).attr(‘dispId’); pcSavePort(0,1,dispId); }); } $ (‘.mc-modal-close’).on(‘click’,function(){ $ (‘.mc-modal-wrap’).css(‘display’,’none’); $ (‘.mc-modal’).removeClass(‘success’); $ (‘.mc-modal’).removeClass(‘error’); }); function overlayPopupWatchlist(e, t, n,stkId) { $ (‘.srch_bx’).css(‘z-index’,’999′); typparam1 = n; if(readCookie(‘nnmc’)) { var lastRsrs =new Array(); lastRsrs[e]= stkId; if(lastRsrs.length > 0) { var resStr=”; let secglbVar = 1; var url = ‘//www.moneycontrol.com/mccode/common/saveWatchlist.php’; $ .get( “//www.moneycontrol.com/mccode/common/rhsdata.html”, function( data ) { $ (‘#backInner1_rhsPop’).html(data); $ .ajax({url:url, type:”POST”, dataType:”json”, data:{q_f:typparam1,wSec:secglbVar,wArray:lastRsrs}, success:function(d) { if(typparam1==’1′) // rhs { var appndStr=”; //var newappndStr = makeMiddleRDivNew(d); //appndStr = newappndStr[0]; var titStr=”;var editw=”; var typevar=”; var pparr= new Array(‘Monitoring your investments regularly is important.’,’Add your transaction details to monitor your stock`s performance.’,’You can also track your Transaction History and Capital Gains.’); var phead =’Why add to Portfolio?’; if(secglbVar ==1) { var stkdtxt=’this stock’; var fltxt=’ it ‘; typevar =’Stock ‘; if(lastRsrs.length>1){ stkdtxt=’these stocks’; typevar =’Stocks ‘;fltxt=’ them ‘; } } //var popretStr =lvPOPRHS(phead,pparr); //$ (‘#poprhsAdd’).html(popretStr); 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alert(‘Please select at least one ‘+disNam); } } else { AFTERLOGINCALLBACK = ‘overlayPopup(‘+e+’, ‘+t+’, ‘+n+’)’; commonPopRHS(); /*work_div = 1; typparam = t; typparam1 = n; check_login_pop(1)*/ } } function pcSavePort(param,call_pg,dispId) { var adtxt=”; if(readCookie(‘nnmc’)){ if(call_pg == “2”) { pass_sec = 2; } else { pass_sec = 1; } var postfolio_url = ‘https://www.moneycontrol.com/portfolio_new/add_stocks_multi.php?id=’+dispId; window.open(postfolio_url, ‘_blank’); } else { AFTERLOGINCALLBACK = ‘pcSavePort(‘+param+’, ‘+call_pg+’, ‘+dispId+’)’; commonPopRHS(); /*work_div = 1; typparam = t; typparam1 = n; check_login_pop(1)*/ } } function commonPopRHS(e) { /*var t = ($ (window).height() – $ (“#” + e).height()) / 2 + $ (window).scrollTop(); var n = ($ (window).width() – $ (“#” + e).width()) / 2 + $ (window).scrollLeft(); $ (“#” + e).css({ position: “absolute”, top: t, left: n }); $ (“#lightbox_cb,#” + e).fadeIn(300); $ (“#lightbox_cb”).remove(); $ (“body”).append(”); $ (“#lightbox_cb”).css({ filter: “alpha(opacity=80)” }).fadeIn()*/ $ (“.linkSignUp”).click(); } function overlay(n) { document.getElementById(‘back’).style.width = document.body.clientWidth + “px”; document.getElementById(‘back’).style.height = document.body.clientHeight +”px”; document.getElementById(‘back’).style.display = ‘block’; jQuery.fn.center = function () { this.css(“position”,”absolute”); var topPos = ($ (window).height() – this.height() ) / 2; this.css(“top”, -topPos).show().animate({‘top’:topPos},300); this.css(“left”, ( $ (window).width() – this.width() ) / 2); return this; } setTimeout(function(){$ (‘#backInner’+n).center()},100); } function closeoverlay(n){ document.getElementById(‘back’).style.display = ‘none’; document.getElementById(‘backInner’+n).style.display = ‘none’; } stk_str=”; stk.forEach(function (stkData,index){ if(index==0){ stk_str+=stkData.stockId.trim(); }else{ stk_str+=’,’+stkData.stockId.trim(); } }); $ .get(‘//www.moneycontrol.com/techmvc/mc_apis/stock_details/?sc_id=’+stk_str, function(data) { stk.forEach(function (stkData,index){ $ (‘#stock-name-‘+stkData.stockId.trim()+’-‘+article_id).text(data[stkData.stockId.trim()][‘nse’][‘shortname’]); }); }); function redirectToTradeOpenDematAccountOnline(){ if (stock_isinid && stock_tradeType) { window.open(`https://www.moneycontrol.com/open-demat-account-online?classic=true&script_id=$ {stock_isinid}&ex=$ {stock_tradeType}&site=web&asset_class=stock&utm_source=moneycontrol&utm_medium=articlepage&utm_campaign=tradenow&utm_content=webbutton`, ‘_blank’); } }
Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic Fulvestrant injection used in treatment of breast cancer.
The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement.
The approved injection is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, of AstraZeneca Pharmaceuticals LP, it added.
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer, the company said. For 12 months ended September 2022, Fulvestrant injection, 250 mg/5 mL, had an estimated market size of USD 71 million, the company said citing IQVIA data.
