Navigation Links
Aurobindo Receives Approval from USFDA for anti-AIDS drug

AIDS patients, the world over, can heave a sigh of relief following the nod of approval from the US Food & Drug Administration// (FDA) for the world’s first anti-AIDS cocktail drug for use as a single dose.

The drug manufacturer, Hyderabad-based bulk drugs major Aurobindo Pharma, has made combined anti-retro virals (ARVs) — Retrovir (zidovudine), Epivir (lamivudine) and Viramune (nevirapine) into a single three-in-one fixed dose drug.

The World Health Organisation (WHO) recognizes the three drugs as the first line of therapy for AIDS and they constitute about 50% of drug therapy against the disease.

Therefore the combination of the three drugs as a single tablet will result in fewer dosages as well as side-effects making life much easier for patients. Otherwise these patients have to consume about 20-30 pills a day for the Highly Active Antiretroviral Therapy (HAART) in treating AIDS.

With the US FDA approval means the drug can be sold immediately in over 15 countries as part of the $15 billion US President’s Emergency Plan for AIDS Relief (PEPFAR) programme.

Besides this, since the combination drug has now become a new drug it can receive new drug approval (NDA) and sold in the US markets, once the patents on the individual components expire. The combined market for these three drugs is estimated at a whopping $5 billion annually in the US alone.

The patents for these drugs in the US market expire in 2009 and 2010.

According to Lanka Srinivas, director, Aurobindo Pharma, 'This is indeed a major milestone for Aurobindo and, in fact, the whole country. What is further significant is that this is the first triple combination filing approved by the US FDA and, in fact, the first one ever filed.'

Lanka added that Aurobindo is targeting over $100 million in total revenues from the export of ARVs next year from the current $60 million.

'"/>




Page: 1

Related medicine news :

1. Aurobindo gets U.S. FDA approval for Cephalexin
2. US FDA approved Aurobindo Pharma to produce generic AIDS drug
3. Aurobindo Gets Tentative USFDA Approval For Its HIV-1 Drug
4. Aurobindo Pharma Purchases US Manufacturing Facility
5. Aurobindo Gets USFDA Approval for Didanosine Chewable Tablets
6. Aurobindo Gets USFDA Approval for A 3-Drug Combination Pack
7. Fifth US Patient Receives Artificial Heart
8. Northfield Labs Receives FDA Comments
9. British MPs Say Prostate Cancer Receives Low Priority in the NHS
10. Abbott Receives CE Mark Certification
11. Zactima Receives Fast Track Designation By The FDA
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:4/26/2017)... ... 26, 2017 , ... Journal of Oral Implantology – Tooth loss ... overall dental health, including complications with speech, eating, and overcompensation of mouth due to ... lost teeth. As the number of tooth replacements increase, it is imperative to design ...
(Date:4/26/2017)... ... April 26, 2017 , ... Elisabete Miranda, president and CEO ... Enterprising Women magazine as one of its 2017 Enterprising Women of the Year, ... have demonstrated that they have fast-growth businesses, mentor or actively support other women ...
(Date:4/26/2017)... ... April 26, 2017 , ... RawTrition now brings you ... to get nutrients from SUPERFOODS! , RawTrition is taking nutrients to the ... level because the body recognizes its raw form (unlike the synthetically made options that ...
(Date:4/26/2017)... FL (PRWEB) , ... April 26, 2017 , ... ... and human performance, is proud to announce that it has received 510(k) clearance ... technologies, the MyoCycle Home and the MyoCycle Pro. , Both devices are stationary ...
(Date:4/25/2017)... ... 25, 2017 , ... Coalition Duchenne, a ... muscular dystrophy, and funding for Duchenne research, congratulates Capricor Therapeutics on positive ... trial in Duchenne announced today. , Coalition Duchenne funded studies carried out ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... , April 19, 2017 Cardiology devices segment ... projected period The Cardiology Devices segment is likely ... US$ 15 Mn in 2018 over 2017. By the end ... market valuation close to US$ 700 Mn, expanding at a ... segment dominated the Asia Pacific reprocessed ...
(Date:4/19/2017)... , April 19, 2017  Vanderbilt University Medical ... patients in Nashville , Tennesse have ... Esophageal Sphincter Stimulation for GERD (LESS GERD) trial. The ... provide long-term reflux control by restoring normal function to ... 65 million people in the United States ...
(Date:4/19/2017)... HANOVER, N.J. , April 19, 2017 /PRNewswire/ ... conducted by the National Heart, Lung, and Blood ... (NIH) demonstrating that 58% of patients with treatment-naïve ... six months when treated with eltrombopag at the ... 1 . The study evaluated three sequential treatment ...
Breaking Medicine Technology: