Navigation Links
Tamiflu 30 Mg and 45 Mg Capsules Approved by FDA

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to market Tamiflu(R) (oseltamivir phosphate) capsules in 30 mg and 45 mg doses. The lower dose capsules provide a convenient alternative for the treatment and prevention of influenza types A and B in patients one year and older. Since the capsules have a longer shelf life than the liquid suspension formulation (five years vs. 24 months), they also offer an improved option for government pandemic stockpiling.

Tamiflu will continue to be available in a 75 mg capsule for adults as well as liquid suspension formulation for children. The 30 mg and 45 mg capsules will be available in pharmacies nationwide and for government stockpiling for the 2007-2008 flu season. To date, Roche has filled orders from the U.S. federal government and states for 43.7 million Tamiflu treatment courses.

"Roche continues to take steps to facilitate the use of antivirals in pandemic preparedness and response," said Dominick Iacuzio, Ph.D, medical director at Roche. "These lower dose capsules not only provide governments with a new option for pandemic stockpiling, but also give prescribing physicians an alternative for patients who prefer a capsule formulation."

The sNDA was filed in March based on data already available for the 75 mg capsule. The method of manufacturing will remain the same; the only change will be the size of the capsule and the amount of the active ingredient, oseltamivir phosphate, filled into the capsule. Tamiflu is the only neuraminidase inhibitor approved for use in children one to five years of age.

Influenza is a serious illness that affects up to 40 million Americans every year, leading to approximately 200,000 hospitalizations and 36,000 deaths.(1) Research indicates that children are especially vulnerable to influenza and its complications. On average, one in three children in the U.S. is affected by influenza annually.(2) Children are also two to three times more likely than adults to get sick with the flu, according to the National Institute for Allergies and Infectious Diseases (NIAID).(3)

Additionally, children represent one of the most important links in influenza transmission.(4) Experts believe that compared with adults, children do not have as much natural immunity to influenza because they have had less lifetime exposure. Close contact with each other in school, home and daycare settings increases children's risk of getting and spreading the virus.

The Centers for Disease Control and Prevention (CDC) recommends three steps to protect against influenza: vaccination, good health/hygiene habits, and antiviral medications. When taken within 12-48 hours of symptom onset, antiviral medications like Tamiflu can help reduce the duration of symptoms.

Tamiflu can also be used preventively to help avoid the flu altogether. Clinical trials have shown Tamiflu to be up to 89 percent effective in preventing influenza illness when taken within 48 hours of exposure, which can help control spread in schools and other crowded settings.


'"/>




Related medicine news :

1. Tamiflu Shortage Can Be Better Handled By Combining It With Probenecid
2. India To Procure 1 Million Doses Of Tamiflu
3. US Reviews Risks Of Tamiflu After 12 Children Die
4. US Regulator Sees No Link Between Tamiflu And Japan Deaths
5. Roche confirms Tamiflu production talks in US
6. Dosage Of Tamiflu Sought To Be Increased
7. Tamiflu Fails To Save Two Lives
8. Christmas trees to yield key Tamiflu ingredient
9. India to produce Tamiflu generic ‘Oseltamivir
10. A success for the Indian pharmacy: gets licence to manufacture Tamiflu
11. Hyderabad Firm To Manufacture Tamiflu In India
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet ... product that was developed to enhance the health of felines. The formula is all-natural ... two main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews ...
(Date:6/25/2016)... ... ... of Bruton Memorial Library on June 21 due to a possible lice infestation, as reported ... head lice: the parasite’s ability to live away from a human host, and to infest ... in the event that lice have simply gotten out of control. , As lice are ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... ... 2016 , ... Marcy was in a crisis. Her son James, eight, was out of control. ... and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... rocks at my other children and say he was going to kill them. If ...
(Date:6/24/2016)... ... , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business ... to $12 an hour by 2020 and then adjusting it yearly to increase at the ... minimum wage, assure the wage floor does not erode again, and make future increases more ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/23/2016)... 2016 Research and Markets has announced ... Forecast to 2022" report to their offering. ... the patients with kidney failure, it replaces the function of ... patient,s blood and thus the treatment helps to keep the ... balance. Increasing number of ESRD patients & ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Medical Market Analysis 2016 - Forecast to 2022" report ... The report contains up to date financial data derived from ... of major trends with potential impact on the market during ... market segmentation which comprises of sub markets, regional and country ...
Breaking Medicine Technology: