Ebene Magazine – Drug maker Caplin Steriles gets USFDA approval for an injection en

0
1

Press Trust of India  | 
New Delhi 
Last Updated at April 19, 2021 16:54 IST

Drug firm Caplin Point Laboratories on Monday said its arm Caplin Steriles has received final nod from the US health regulator for generic Milrinone Lactate injection, used for short-term intravenous treatment of patients with acute decompensated heart failure.

Caplin Steriles has been granted « final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Milrinone Lactate Injection USP, 10 mg/10 mL (1 mg/mL), 20 mg/20 mL (1 mg/mL), 50 mg/50 mL (1 mg/mL), single-dose vial presentation…, » Caplin Point Laboratories said in a filing to BSE.document.write(« « );googletag.cmd.push(function(){googletag.defineOutOfPageSlot(‘/6516239/outofpage_1x1_desktop’,’div-gpt-ad-1490771277198-0′).addService(googletag.pubads());googletag.pubads().enableSyncRendering();googletag.enableServices();});

The product is a generic version of Sanofi-Aventis U.S. LLC’s, Primacor injection in the strength of 1 mg/mL, it added.

According to IQVIA data, Milrinone Lactate injection had US sales of around USD 24 million for the 12-month period ending Dec 2020, for both the vial and bag presentations, the filing said.

The product is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure, it added.

Shares of Caplin Point Laboratories were trading at Rs 494.30 per scrip on BSE, up 6.03 percent from its previous close.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is happy to inform you of the launch of « Business Standard Premium Services »

As a premium subscriber you get an across device unfettered access to a range of services which include:

Welcome to the premium services of Business Standard brought to you courtesy FIS.
Kindly visit the Manage my subscription page to discover the benefits of this programme.
Enjoy Reading!
Team Business Standard

Related title:
Caplin Steriles gets USFDA nod for an heart injection
Drug maker Caplin Steriles gets USFDA approval for an injection
Caplin Point Laboratories share price up 8% on USFDA approval for ANDA
Caplin Point Lab's subsidiary receives USFDA nod for Milrinone Lactate Injection; Stock jumps 7%

en

Ref: https://www.business-standard.com

QU’EN PENSEZ-VOUS?

[comment]

PUB

Laisser un commentaire, votre avis compte!

[gs-fb-comments] [comment-form]

Laisser un commentaire, votre avis compte!