Approva

Ranbaxy gets US FDA approval for Lisinopril

Ranbaxy Pharmaceuticals Inc (RPI) has received a tentative approval from the US FDA for Lisinopril tablets. Lisinopril is recommended for hypertension, either alone for initial therapy or with other classes of anti-hypertenive agents. It is also used as adjunctive therapy in the management of heart failure and patients who do not respond to diuretics. // However it expects to launch...

Approval for DNA test to detect cystic fibrosis

Food and Drug Administration (FDA) of US had approved the first test that// uses DNA in blood to diagnose cystic fibrosis. The test is called Tag-It Cystic Fibrosis Kit and it can analyze DNA samples from the blood and detect genes that carry the strains of the disease, both in children and in adults. The test can not only predict the advent of the disease in people, but it can also id...

Aurobindo gets U.S. FDA approval for Cephalexin

Aurobindo Pharma Ltd has announced that U.S. Food Drug Administration (US FDA) has approved its Cephalexin capsules USP 250 mg & 500 mg.// Cephalexin is used to treat many different types of bacterial infections such as bronchitis, tonsillitis, ear infections, skin infections, and urinary tract infections.The company has achieved another major milestone by obtaining the first product...

Cadila gets US FDA approval for Promethazine tablets

Cadila Healthcare Ltd has received US Food Drug Administration (US FDA) approval to market Promethazine tablets 12.5 mg, 25 mg and 50 mg in the US.// Promethazine is an anti-emetic drug, used to treat allergic symptoms and reactions, to cause sedation, to assist in controlling postoperative pain and to control motion sickness. The company plans to launch the drug in US this ye...

Vaccine For Cervical Cancer Awaits Approval

Sanofi Pasteur MSD is in the process of developing a vaccine called Gardasil against cervical cancer. The regulatory approval for the new vaccine is being sought by the organization in Europe and the US.// The European Medicines Agency for Sanofi Pasteur MSD has to approve of the marketing authorization for selling the product in Europe. Gardasil is reported to have a decided advantage...

WHO Gives Its Approval For Bird Flu Test Kit

The go ahead has been given by the World Health Organization (WHO) towards developing a bird flu test kit aimed at pinpointing the H5N1// strain in just a matter of three hours. The developers of the kit are based in Singapore. The kit from Veredus Laboratories, launched in July, was found by the WHO Collaborating Center for Influenza in Australia to be highly specific to the deadly bird...

Anti-obesity drugs for FDA approval

Two obesity reducing drugs are awaiting FDA approval and if approved could provide the pharmaceutical manufactures with high profits due to sales of these drugs. These new drugs are to be reviewed by the federal regulators before it could be available as a counter sales drug.// Acomplia and Alli are the two new anti-obesity drugs and could help in weight loss management. Acomplia is m...

FDA Gives Its Approval For Inhaler

An inhaler which is capable of regulating the blood sugar level has received the approval from the US Food and Drug Administration (FDA). // This inhaler will be a source of relief to those people who are suffering from diabetes. The hand-held Exubera inhaler is a rapid-acting, dry powder human insulin that is inhaled through the mouth prior to eating. It weighs four ounces and, when...

RotaTeq Gets US Approval

A vaccine called RotaTeq for rotavirus has been approved by the US. The rotavirus which gives rise to vomiting and diarrhea claims the lives of about 500,000 children across the world annually. // In one of the largest clinical trials in history, Merck, the medicine's maker tested the vaccine on more than 70,000 children that showed it was safe and remarkably effective. Rotavirus is a...

Better Communication With FDA Could Speed Up Approval Of New Drugs

A new report commissioned by the Food and Drug Administration has found that newer medicines could hit the markets sooner if regulators met with the drug makers and apprised them of their concerns regarding that particular// medication before it went into the final phase of human testing. The report by consulting firm Booz Allen Hamilton, on behalf of the FDA said that 53 percent of dru...

Nerve Stimulator for Depression Though Not Effective Was Given Approval

A pacemaker-like device which has to be surgically implanted called the vagus nerve stimulator was approved by a top federal medical official against the opinion of his scientific staff . // This device is used in the treatment of persistent depression. As it was no approved by the staff due to its ineffectiveness in its only clinical trial, it was rejected. Cyberonics Inc is the maker...

Grand FDA nod and approval for drug for heart transplant patients

In a relief FDA, the U.S. health regulators, gave their nod to the first new drug in nearly a decade to prevent organ rejection in heart transplant patients.// The drug, Astellas Pharma Inc.'s Prograf, is already cleared to prevent rejection of liver and kidney transplants. Dr. Steven Galson, head of the FDA's Center for Drug Evaluation and Research said, "The doctors who perfo...

OTC sale for Xenical; Diet Drug; gets FDA approval

Prescription diet drug Xenical manufactured by GlaxoSmithkline got a nod for OTC sale from FDA.It received an "approvable" letter from the Food// and Drug Administration so that it can be marketed once the company addresses additional questions from regulators. An estimated arrival time for the sale is early next year. It would become the first F.D.A.-approved weight-loss product sold...

Medtronic’s Insulin Pump Receives Regulatory Approva

The U.S. Food and Drug Administration has approved Medtronic's MiniMed Paradigm insulin pump, which is also a glucose monitor. This is the first device to deliver // insulin as well as monitor glucose levels in the blood. The MiniMed takes blood glucose every five minutes and gives 288 readings per day. It consists of two components, one of which is an electrode inserted under the skin....

Ranbaxy Gets USFDA Approval For Doxycycline Tablets

Ranbaxy Laboratories Ltd has received approval from USFDA for manufacturing and marketing Doxycycline Tablets in the US market.// The company informed the Bombay Stock Exchange that it got the approval for marketing the antibiotic in strengths of 50mg, 75mg and 100mg. Doxycycline is indicated for a variety of infections caused by susceptible strains or micro-organisms inclu...

Global Education Net Pvt Medical College Gets MCI Approval

The proposed private medical college of Global Education Net here has received Medical Council of India clearance for starting first year MBBS course. // Tripura Health minister Tapan Chakraborty told reporters that the decision to provide approval to B R Ahmbedkar Hospital, run by Global Education Net (GENET) for starting the MBBS course was taken in the meeting of the Medical Counci...

Approval of Drugs for the Treatment of Late-Stage Cancer

The U.S. Food and Drug Administration have approved a combination of Hycamtin (chemical name, topotecan hydrochloride) and cisplatin to be //used as the first drug treatment for women with late-stage cancer of the cervix at which stage surgery or radiation therapy are often ineffective. The agency has also approved Gardasil as the first vaccine developed to prevent cervical cancer. Hycamt...

Lupin Gets USFDA Approval For Quinapril Tablets

Pharmaceutical company Lupin Ltd today said it has recieved the final approval from USFDA to market its Abbreviated New Drug Application (ANDA) of hypertension medicine Quinapril in US. // The company informed the Bombay Stock Exchange that the approval is for the multiple dosages of strengths 5 mg, 10 mg, 20 mg and 40 mg. Quinapril is a AB-rated generic equivalent of Pfiz...

Cipla's HIV Drug Gets FDA Approval

Pharma giant Cipla has received the approval from the Food and Drug Administration for its "abbreviated new drug application (ANDA) for anti-HIV/AIDS// drug Slamivudine," according to a posting on the FDA site. The website reported that the tentative approval for ANDA is for an oral solution with strength of 10mg per ml. The new drug belongs to a class of drugs called as nucleoside re...

Lenalidomide, Granted Approval by FDA to Join Multiple Myeloma Drugs

Graham Burton, M.D., SVP, Regulatory Affairs and Pharmacovigilance said that FDA’s approval of REVLIMID (lenalidomide) offered a new oral drug option// to the group of people suffering from multiple myeloma. Celgene Corporation (Nasdaq: CELG) announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Supplemental New Drug Application (sNDA) for an additional...

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 (nevira...

Aurobindo Gets Tentative USFDA Approval For Its HIV-1 Drug

Aurobindo Pharma today said it has recieved a tentative New Drug Approval from USFDA for its fixed dose combination product used for treating HIV-1 infection//. The new drug approval is for fixed dose combination drug product containing Lamivudine, Zidovudine, Nevirapine tablets used in the treatment of HIV-1 infection, the company informed the Bombay Stock Exchange. The t...

FDA Approval For Lucentis

The first drug proven to significantly improve the vision of elderly patients was approved by the FDA on Friday//. The drug, Lucentis, is to treat age-related macular degeneration in its wet form, where blood vessels behind the retina leak, worsening vision and often leading to blindness. 90 percent of the 1.4 million Americans, who have lost their vision due to this degeneration, are...

Harney Seeks Approval for New Medical Practitioners Bill

Health Minister Mary Harney has plans to introduce new legislation to regulate doctors, due to be published within the next week or so//. She is seeking Government approval in order to publish heads of bill for new legislation next week or the following week so that a new Medical Practitioners Bill can be published later this year. Although changes to the existing Medical Practi...

Drug Company Seeks Approval for Human Testing of Vaccine against H5N1 Virus

British Drug company, PowerMed is seeking approval for conducting the first human trials of experimental vaccine against the deadly strain of avian flu virus H5N1//. The World Health Organisation has reported 97 human cases of avian flu since December 2003, with at least 53 deaths. The company has submitted its plans for the trial to the UK Medicines and Healthcare Products Re...

Aurobindo Gets USFDA Approval for Didanosine Chewable Tablets

Aurobindo Pharma Ltd today said it has received tentative approval by USFDA for its anti-HIV drug, Didanosine chewable tablets of 100mg, 150mg and 200mg strengths. // This is the first generic version approval for Didanosine chewable in the world given by USFDA, Aurobindo Pharma informed the Bombay Stock Exchange. The aforesaid product would now be available for purchase un...

POLY Medicure Ltd Applies for 8 Patents, 2 FDA Approvals

Poly Medicure Ltd today said it has applied for eight new patents and two USFDA approvals for its new range of safety syringes and safe blood collection holders. // "In our latest safety syringe, the needle retracts back in the plunger and gets locked after administering the shot so that it does not remain exposed after use. The important feature is that it cannot be reused preventing...

Approval Given for Two Medical Colleges In Karnataka

The Centre and the Medical Council of India have accorded sanction to the Karnataka government to start two of six new medical colleges it had proposed from this academic year, the state assembly was informed today. // The two new colleges will start functioning in Belgaum and Mandya, Medical Education Minister V S Acharya said while making a statement in the House. The MCI...

Lupin Gets USFDA Approval for Meloxicam

Lupin Ltd today said it has got the approval of US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Meloxicam tablets used in the treatment of osteoarthritis and rheumatoid arthritis. // The approval is for Meloxicam tablets of strengths of 7.5 mg and 15 mg , the company informed the Bombay Stock Exchange. "The approval of our Meloxi...

Sunscreen Blocking UVA Radiation Receives Federal Approval

A type of sunscreen that blocks the kind of ultraviolet radiation which has been linked to some cancers and available only outside the United States, has received// federal approval on Monday. While other sunscreens mainly block UVB rays Anthelios SX contains ecamsule, which is an ingredient that can block ultraviolet A, or UVA, radiation better than other sunscreen ingredients, which a...

Aurobindo Gets USFDA Approval for A 3-Drug Combination Pack

The Hyderabad-based Aurobindo Pharma Ltd today said it has received the tentative new drug approval for a fixed drug combination product used for anti-HIV treatment. // The fixed drug compbination product contains Lamivudine 150mg+2idovudine300mg tablets co-packaged with Abacavir 300mg Tablets, the company informed the Bombay Stock Exchange. This combination pack enhances c...

Orchid gets FDA Approval for Cefotaxime Injections

Orchid Chemicals & Pharmaceuticals, a leading player in the Indian drug industry, has received a formal approval from the US Food and Drug Authority (FDA) for three// of its abbreviated new drug applications (ANDAs) for Cefotaxime. Orchid will be launching this product in the US through its exclusive distribution partner, Apotex, the Chennai-based company said in a release Wednesday....

Approval imminent for Herceptin in Alberta

The Alberta Cancer Board has indicated that the Klein Government is all set to give the approval to fund the drug, Herceptin, for early stage breast cancer.// The spokeswoman of the board, Lee Elliot said, they were awaiting the outcome of the clinical trials in the United Kingdom before advising the $40,000-per-patient drug regime to the entire province. Presently Herceptin is avail...

First Implantable artificial heart gets FDA’s approva

The first completely implantable artificial heart was approved by the U.S. Food and Drug Administration (FDA) on Tuesday.// The artificial heart has been approved for patients with severe heart problem, who are too ill for a heart transplant. Under the FDA's Humanitarian Use Device provisions, the device, the AbioCor Implantable Replacement Heart, was approved. However, it restricts the...

FDA Gives Approval for Skin Cancer Drug, Zolinza

Zolinza, the most recent skin cancer drug has today received approval from the U.S. Food and Drug Administration (FDA). Zolinza (vorinostat) capsules is mainly recommended// for the treatment of cutaneous T-cell lymphoma (CTCL) type of skin cancer when the disease persists, worsens, or returns during or after treatment with other medicines. Zolinza has been approved as part of FDA's Orp...

FDA Approval for Lung Cancer Treatment -Avastin Along with Chemotherapy

The FDA has approved the drug bevacizumab (Avastin) for first time treatment of advanced lung cancer in conjunction with chemotherapy. // This comes after a large randomised study on lung cancer patients led by Dr.Alan Sandler, lung cancer specialist and director of Thoracic Oncology at Vanderbilt-Ingram Cancer Center. Nearly 900 patients with non-small cell lung cancer (NSCLC) were t...

LA County gives Approval for Reform Plan for King-Drew Medical Center

LA County leaders voted on Tuesday to beg the federal government to continue to fund the troubled Martin Luther King Jr.-Drew Medical Center while they undertake// a drastic downsizing to save the inner-city hospital from folding. The County Board of Supervisors has unanimously approved the reform plan for submission to the Centers for Medicare and Medicare Services. Health officials hav...

Astra Zeneca's Seroquel Gets FDA Approval For Schizophrenia

Seroquel(quetiapine) has been approved by the FDA for treating both manic and depressive forms of bipolar disorder, Astra Zeneca announced on Monday. The drug was// previously used for treating the manic form of the disease and schizophrenia, as are Zyprexa(Eli Lilly & Co), Risperdal(J&J) and Abilify(Bristol-Myers Squibb Co). These drugs have fewer side effects unlike the older anti-p...

Ranbaxy Gets FDA Approval for Depression Drug

India's drug major Ranbaxy Laboratories has received the US Food and Drug Administration (FDA)'s final approval to manufacture// and market its formulation for the treatment of major depressive disorders in adults. Ranbaxy Pharmaceuticals Inc. (RPI), a wholly-owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced Friday that FDA approval permitted the Indian company to make...

Mylan Announces Final FDA Approval for Fluoxetine Capsules

Mylan Laboratories Inc. (NYSE: MYL) announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 40 mg. Fluoxetine Capsules are the generic version of Eli Lilly and Company's Prozac(R) Capsules. Fluoxetine Capsules had U.S. sales of app...