Glenmark Pharma gets final nod from USFDA for cholesterol lowering drug

The approved product is a generic version of Daiichi Sankyo Inc's Welchol

1487946007-1677

Health News : Glenmark Pharmaceuticals has received final approval from the US health regulator for Colesevelam Hydrochloride for oral suspension, used to lower cholesterol levels in the blood.

The approval has been granted by the United States Food and Drug Administration (USFDA) in the strengths of 1.875 grams/packet and 3.75 grams/packet, the company said in a BSE filing on Tuesday.

The approved product is a generic version of Daiichi Sankyo Inc's Welchol.

Quoting IQVIA sales data for the 12-month period ended May 2018, the company said Welchol achieved annual sales of around $73 million.

The company's current portfolio consists of 138 products authorised for distribution in the US market, and 62 Abbreviated New Drug Applications (ANDAs) are pending approval with the USFDA, it added. Read Complete Article
 

Comments

Post a Comment

Popular posts from this blog

The Flipkart-ebay deal and the high stake battle with Amazon

Image
Flipkart has been and will continue to make acquisitions to increase scale India's top e-commerce firm   Flipkart   has raised $1.4 billion in its biggest fundraising to date as it takes on US tech giant   Amazon.com   Inc for a larger share of the country's burgeoning online retail market. Chinese social media and entertainment firm Tencent Holdings Ltd, the world's biggest software company Microsoft Corp and online marketplace eBay Inc participated in the funding round, Flipkart said in a statement on Monday, which will value the Indian company at $11.6 billion. That is lower than the $15 billion valuation achieved at its last fundraising in 2015, reflecting how competition has intensified in the e-commerce sector as companies vie for a slice of the world's fastest-growing internet services market. Amazon last year said it would invest over $5 billion in India, and has recently expanded into online video and grocery shopping, seeking to expand aggressively
Read more

Amazon now has customers in 100% serviceable pin-codes in India: Jeff Bezos

Image
If things fall in place, then a deal with a major offline retailer might happen by the end of this year, according to a source Amazon might be the most visited shopping site in India, but for Jeff Bezos, the founder and CEO of the technology giant, it is still Day 1 in what may be the second-most important market for the firm outside the US. Bezos, in a letter to customers, said that Amazon now has customers in 100 per cent serviceable pin-codes in the country and is shipping packages from more than 50 fulfillment locations in 13 states. From talking about how Alexa plays devotional songs in local Indian languages to Amazon India working closely with communities in rural areas, Bezos said that the online marketplace has now become part of the country's culture and has adapted all its services and offerings accordingly. Stressing that Amazon India has captured the top spot for the last two years, Bezos pointed out that Amazon is the most visited site in the cou
Read more

Hypertension drug recall by USFDA shot in the arm for some drug majors

Image
The recall was due to an impurity (N-Nitrosodimethylamine or NDMA) which was found in the recalled products that include valsartan and its combinations   The recent recall of a common  hypertension drug  in the US due to contamination with a carcinogen has opened up short-term opportunities for a handful of Indian players. The issue with sartan (hypertension drug) began around July, when the US Food and Drug Administration (USFDA) notified health care professionals of a voluntary recall of several drug products containing the active ingredient valsartan. Valsartan is used to treat high blood pressure and heart failure. The recall was due to an impurity (N-Nitrosodimethylamine or NDMA) which was found in the recalled products that include valsartan and its combinations. According to the USFDA’s list of products under recall, four companies - Teva, Prinston, Torrent, and Hetero - have recalled products containing the valsartan active ingredient. The USFDA also place
Read more