Imitrex delay: Ranbaxy's loss may be gain for Dr Reddy's Jan 4, 2009
New Delhi (PTI): The delay in Ranbaxy Laboratories getting approval from the USFDA for launching generic version of GlaxoSmithKline's (GSK) migraine and headache drug Imitrex could turn out to be a gain for Hyderabad-based Dr Reddy's Laboratories, which has already launched the drug in the US. ... Ranbaxy has not got approval from the USFDA for launching the generic copy of Imitrex after it came under the scanner of the health regulator, which last year banned 30 of its generic drugs produced at... (Hindu)
Ranbaxy, US Firm In Pact To Market Gliadel Tabs In India Dec 4, 2008
Gliadel is the only US Food and Drug Administration (USFDA) approved drug which is used during surgical resection, providing localized delivery of chemotherapy directly into the cavity created when a brain tumor is removed during surgery. or to post comments. (TopNews)
Spencer Forrest's X5 Web Site Gets a Facelift; Aims to Educate Consumers About Beating Hair Loss Nov 28, 2008
If cleared, the X5 will become only the fourth ever product to receive USFDA recognition for the cessation of hair loss and the stimulation of hair growth in males with hereditary balding. About Spencer Forrest Inc. -- Spencer Forrest Inc. was founded in 1981 and has singularly revolutionized the cosmetic hair loss treatment industry. (Yahoo News -- Press Releases)
Strides Arcolab gets USFDA approval for manufacturing unit Oct 8, 2008
Strides Arcolab, one of the leading Indian pharmaceutical company, has informed that the U.S. Food and Drug Administration (USFDA) had approved its oral dosage manufacturing unit in Bangalore. Following this approval, Strides will be able to export drugs with regulatory approval to the United States. (TopNews)
Ranbaxy drugs in US AIDS programme under scanner Sep 24, 2008
The development follows the US Food and Drug Administrations (USFDA) ban on Ranbaxys 30 generic drugs and seven APIs. Currently, USCEC is conducting a broad investigation into the ability and willingness of the USFDA to enforce laws protecting the public from unsafe food and drugs. (Economic Times)
Doctor's Orders Sep 20, 2008
At a time when the pharmaceutical industry is a sunrise sector of the Indian economy, the US Food and Drug Administration (USFDA) decision to block entry of 30 generic drugs produced at two of Ranbaxy's Indian plants comes as bad news ... Ranbaxy's shares fell 10 per cent immediately after the USFDA's ruling ... It may well be that the USFDA acted under political pressure, since US Congress has instituted a probe into alleged negligence on its part. (India Times, India)
USFDA Warned Ranbaxy Sep 19, 2008
The US Food and Drug Administration have put its report on its website. products of Indian medicine major, Ranbaxy do not conform to the safety standards set by the inspection agency of US. It has banned 31 drugs produced by Ranbaxy. (TopNews)
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)
