Drug cos hit by Patent Act concoction Jul 7, 2008
Globally, patent approvals are anticipated to remain at modest levels until and unless USFDA gets a clear mandate from Congress on improving regulatory pathway for faster approvals, Mr Palnitkar said. Bookmark / Share. (India Times)
USFDA approves device that helped Superman breathe Jun 20, 2008
BEIJING, June 19 (Xinhuanet) -- It worked for Superman, so on Wednesday the U.S. Food and Drug Administration approved a medical device tested about five years ago on actor Christoper Reeve to help him breathe without a ventilator. The NeuRx DPS RA/4 Respiratory Stimulation System is an implantable device developed by Synapse Biomedical Inc. of Oberlin, Ohio. (Xinhuanet, China)
USFDA warns mothers against use of nipple cream May 26, 2008
BEIJING, May 26 (Xinhuanet) -- The U.S. Food and Drug Administration on Friday warned women not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises Inc. of San Rafael, California. The cream, promoted to nursing mothers to help soothe dry or cracked nipples, contains ingredients that may cause respiratory distress, vomiting and diarrhea in infants, the agency said. (Xinhuanet, China)
Some swear by stevia May 14, 2008
" The Center for Science in the Public Interest, a pit bull among consumer organizations, is equally cautious. "The USFDA has rejected stevia for use as a food additive. In sum, small amounts of stevia are probably safe, but it is inappropriate to endorse wide use of this sweetener," says Jeff Cronin, the organization s director of communications. PI;A COLADA SMOOTHIE Yield: 2 (8-ounce) servings1-1/2 cups fresh pineapple juice1/3 cup plain yogurt or kefir1/2 cup pineapple chunks1 teaspoon... (Yuma Daily Sun, AZ)
USFDA grants tentative approval to Sun Pharma's generic anti ... Mar 9, 2008
com : USFDA grants tentative approval to Sun Pharma's generic anti-cancer injection Gemzar ... USFDA grants tentative approval to Sun Pharma's generic anti-cancer injection Gemzar news ... The USFDA has granted tentative approval to Sun Pharmaceutical's abbreviated new drug application (ANDA) for its generic version of Eli Lilly's gemcitabine injection, Gemzar. (domain-B)
Antibiotic May Prevent Dreaded Brain Fever, Study Suggests Feb 22, 2008
The team found that minocycline, an USFDA approved drug, often used to treat acne, limits the death by reducing the microglial activation, neuronal death as well as viral replication. Microglia are cells that act as the "cleanup crew" for the Central Nervous System (CNS). (Science Daily)
USFDA says OTC cold remedies risky for babies, tots Jan 17, 2008
BEIJING, Jan. 16 (Xinhuanet) -- Parents should not give babies and toddler who exhibit cold symptoms over-the-counter cough and cold medicines because they are too risky, the U.S. Food and Drug Administration said Thursday. The federal agency still hasn't decided if the remedies are appropriate for older children to continue using, officials told The Associated Press. (Xinhuanet, China)
No plans for FDA office in India Jan 10, 2008
This was told to reporters by Michael O Leavitt, Secretary of Health and Human Services, US Department of Health and Human Services, and Andrew C. von Eschenbach, Commissioner, USFDA, after visiting Bharat Biotech International Ltd. at Shamirpet near here on Tuesday. Mr. Eschenbach said the FDA wanted to be a bridge and not a barrier to bring the fruits of science and technology to people. (Hindu)
Side effects: Novarits not to market Prexige Nov 23, 2007
The United States Food and Drugs Administration (USFDA) has not approved the medicine, either. Prexige belongs to the class of cox-2 inhibitors, which have been found to have serious side effects. (Business Standard)
Indian pharma prefers non-litigation route in US Nov 22, 2007
This is despite the claims by major Indian players such as Ranbaxy and Dr Reddys at having secured over 20 first to file (FTF) status abbreviated new drug applications (ANDA) with the US Food and Drug Administration (USFDA). The FTF entitles the patent challenger a six-month exclusive selling of generics on the patent expiry of innovator companies under the US law. (Business Standard)
FDA Asks GSK To Place Black Box Warning On Avandia Nov 19, 2007
According to USFDA, Avandias use could give rise to chest pain or coronary failure. More than two million people throughout the world take the drug to treat Type-II diabetes. (TopNews)
ThromboGenics Announces Successful Completion of Technology Transfer to Bharat Biotech for Production of Novel Thrombolytic Agent Sep 4, 2007
The facility's Manufacturing, Control Procedures and Protocols conform to the stringent standards laid down by internationally recognized institutions such as USFDA, UKMCA and WHO. The Company's product line includes INDIKINASE(TM) recombinant Streptokinase, REGEN-D(TM) recombinant Epidermal Growth Factor, TYPBAR(TM) Vi Capsular Polysaccharide Typhoid vaccine, BIOGIT(TM) probiotic yeast, and INDIRAB(TM) anti-rabies vaccine. Bharat Biotech also has a strong pipeline of vaccines to combat Malaria,... (PR Newswire)
AIDS drug maybe effective in cancer Sep 2, 2007
Dennis says that "the concept of screening all drugs for anti-cancer properties has potential", and he hopes that a plan to test every drug approved by the US Food and Drug Administration (USFDA) on tumour cells will go ahead. Loading. (India Times, India)
Plan B Selling Very Well Aug 27, 2007
Plan B is the name of the pill which is marketed by Barr Pharmaceuticals Inc. and was approved by the USFDA in August of 2006. The pill was approved for over the counter purchase for any woman over the age of 18 and is now carried by all large pharmacy chains across the United States. (Dog Flu Diet and Diseases)
United States Doctors for Africa eyes Ghana Jul 12, 2007
Accra, July 11, GNA- United States Doctors for Africa (USFDA), a non-profit organisation, focusing on HIV/AIDS and other infectious diseases in Africa on Wednesday announced plans to introduce its services in Ghana ... USFDA attracts some 3,000 medical personnel who are working mainly in Sub-Saharan Africa ... Mr. John Dwamena, Executive Chairman of the USFDA, who led a four-member delegation of the organisation to call on Vice President Alhaji Aliu Mahama, conferred on him, the Patron of the... (Ghana Web, Ghana)
After BPO, pharma faces US backlash Jun 26, 2007
They have accused India of being a source of low-quality exports and are exerting pressure on US Food and Drug Administration (USFDA) to tighten the oversight on Indian companies ... A former USFDA official has also gone on record to say that the agency does not conduct frequent inspections of FDA-approved plants in India and this is a matter of concern. (India Times)
Cadila gets USFDA nod for marketing 3 drugs Jun 12, 2007
Mumbai, June 12 (PTI): Cadila Healthcare today announced that it has received US Food and Drug Administration (USFDA) approval for marketing its three products in the US.. "The group will market all three drugs through its US subsidiary Zydus Pharmaceuticals (USA) Inc. The group now has 27 approvals since the commencement of filing process in FY 2003-04," the pharma company said in the communique to the BSE.. (Hindu)
Scientists make all blood 'universal' Apr 6, 2007
It also monitors the dynamic of the infection. We can tell how many copies of the infection are present in the body. (Moneycontrol.com)
Trans fat on food labels may become mandatory Feb 24, 2007
The USFDA site, for instance, advises that though restaurants do not have to provide the fat content in prepared food, customers can ask about the kind of oil used in cooking. The biggest source of trans fat in India, says a source at Hyderabad's National Institute of Nutrition (NIN), is vanaspati, which is a hydrogenated fat. (India Times, India -- Intl Business)
3 cos sue Wyeth over Zosyn patent Feb 3, 2007
Chennai-based Orchid Chemicals, Sandoz (Novartis generic arm) and Abraxis Pharmaceutical Products (APP) have filed citizen petitions with the USFDA against Wyeth, after the pharma major filed a new patent on its blockbuster drug Zosyn, extending its patent life to 2023 ... According to USFDA rules, a company is allowed to withdraw a product from the market only for reasons related to safety and efficacy ... "Wyeth has withdrawn its original version of the drug to comply with USFDA regulations.... (India Times)
Toxic Cosmetic Products in Ghana Sep 10, 2006
I have attached, below, a Table that summarizes the findings by a USFDA certified laboratory. I have also attached copies of the certified lab test certificates. (Ghana Web, Ghana)
Erica, Phillip Kenner return from month-long studies in Thailand Jul 11, 2006
AFRIAMS is currently into phase three of a vaccine development for HIV, and if this level of the testing program works, a vaccine will likely be approved by the USFDA. There are nearly 16,000 participants in the project being conducted in Thailand. t was really neat to see all of the work that goes into testing for a possible vaccine,'' says Phillip, who will be a sophomore at Harvard this fall. (Devils Lake Daily Journal, ND)
Aurobindos AIDS cocktail drug receives USFDA nod Jul 3, 2006
DNA - Money - Aurobindos AIDS cocktail drug receives USFDA nod - Daily News sis. Aurobindos AIDS cocktail drug receives USFDA nod C Chitti Pantulu Sunday, July 02, 2006 21:39 IST. (Daily News & Analysis)
Merck's Zocor price cut a mixed bag for drug cos Jun 30, 2006
Conservative estimates suggest that the drug may net around $50 million revenues for Ranbaxy during the 180-day exclusivity period granted to it by USFDA.. Merck recently reduced the price of Zocor, which lost its US patent protection last week, even below the price of the generic versions, for two largest US health insurers United Health Group Inc and WellPoint Inc.. (India Times, India -- Intl Business)
Pharma firms see biotech gain from USFDA nod Jun 12, 2006
NEW DELHI: The recent US Food and Drug Administration (USFDA) approval to a new version of a popular growth-hormone drug, Omnitrope, will open up a huge untapped market for the Indian pharma industry to launch cheaper biotech products soon. Recently, European medicines agency, EMEA also issued firm guidelines for four bio pharmaceuticals - Erythropoietin, Insulin, Human Growth Hormone and Growth Colony Stimulating Factor. (India Times, India -- Intl Business)
Now, pharmas opt for in-licencing deals May 16, 2006
Branded Lupenox, the product will be manufactured in ItalFarmaco s USFDA approved plant at Milan and will be sold by Lupin in India ... We believe Lupenox, being a superior quality product sourced from ItalFarmaco s USFDA approved facility, will serve the needs of patients better, said Sakti Chakraborty, president, India Region Formulations, Lupin. (India Times)
Ghana FDA Must Ban These Dangerous Cosmetic Products May 8, 2006
However, the USFDA has determined that when people use products containing more than 2% hydroquinone over a long period of time, they develop several skin problems, including all kinds of skin colorations. In Ghana, just as in the United States, the permissible legal limit of hydroquinone in skin creams is 2. (Ghana Web, Ghana)
Beyond the N-word Mar 5, 2006
International challenges Expressed satisfaction at the expedited USFDA drug approval processes that strengthen the combat against HIV/AIDS and encourage greater corporate participation to meet this challenge, including the establishment of the Indo-US Corporate Fund for HIV/AIDS. Agreed to expand bilateral efforts and continue cooperation in the area of medical research and strengthen technical capacity in food and drug regulation in India as well as address the concern on avian influenza.... (Indian Express)
The Indo-US joint statement » Mar 3, 2006
Indo-US joint statement : HindustanTimes. Thursday, March 2, 2006. (Hindustan Times, India)
India, US pledge to combat AIDS Mar 3, 2006
The U.S. also supports India's plan to raise the capabilities of its drug- approving agency to those comparable with the USFDA. The introduction of internationally accepted FDA testing standards, would lead to greater confidence and marketability of Indian drugs and foods. Institutions in the two countries have been identified for collaborative research and product development. (Hindu)
Juicy tomatoes could pack in some lung protection says study Jan 11, 2006
Only recently, lycopene proponents suffered a setback when the USFDA ruled that the antioxidant present in red fruits like pomegranates, tomatoes and watermelon was not likely to lower risks of cancer. Whereas at the same time another Harvard University study points to a serving everyday of tomato-based foods in lowering heart disease risks by as high as 30 percent. (Earthtimes.com)
