Oseltamivir (Tamiflu) approved to prevent H1N1 swine flu in infants in Japan

Oseltamivir (Tamiflu) has been approved to use in infants from age 1 as preventive measure to counter H1N1 swineflu infection in Japan.

The Japanese Ministry of Health, Labour and Welfare granted approval for the anti-influenza drug oseltamivir phosphate (Tamiflu) in an additional indication of “prophylaxis of influenza in adults, infants and children” in the formulation as Tamiflu Dry Syrup, Chugai Pharmaceutical Co., Ltd announced in a press statement.

Chugai markets Roche’s Tamiflu in Japan.

Oseltamivir (Tamiflu), newly added indication will enable the prophylaxis – as a preventive- administration of Tamiflu to infants and children under the age of 13.

The Japanese health authorities have also granted approval for a change in the dosage and administration for Tamiflu Capsules in the pediatric prophylaxis indication.

In addition, it has become possible to administer not only Tamiflu Dry Syrup but also Tamiflu Capsules to children with a body weight of 37.5 kg or more, which is the same as in the current indication for treatment of influenza.

For prophylaxis of influenza adults are requird to take the usual oral dosage is 75 mg as oseltamivir once a day for 7 to 10 days.

For infants and children the usual oral dosage is 2 mg/kg as oseltamivir (66.7 mg/kg as Dry Syrup) once a day for 10 days. Tamiflu Dry Syrup is prepared into suspension at the time of use. However, the maximum dose a time is 75 mg as oseltamivir.Japanese

Japanese approval for oseltamivir (Tamiflu) as a preventive medicine against H1N1 swine flu in kids and adults is expected boost the sales of the drug further.

Oseltamivir (Tamiflu) is one of the few options currently available to treat the pandemic H1N1 swineflu infections which is spreading like wildfire across the world.

Roche is already making windfall sales gains from the drug as various countries across the world amass the Oseltamivir (Tamiflu) for their stockpile for using in times of emergency.

In India, several drug makers including Cipla, Hetero Drugs, Strides Arcolab, Natco Pharma, Ranbaxy etc have already launched generic versions of the drug.

Cipla and Hetero have also launched oseltamivir syrup for paediatric use.

Cipla’s Antiflu (oseltamivir) pills are also pre-qualified by the World Health Organisation.

Cipla has the capacity to produce upto 2 million Antiflu (oseltamivir) pills in one month.

Cipla has also offered to supply Antiflu to the United States, where there is shortage of the drug currently, provided they could forego the patent of Roche’ s Tamiflu on grounds of national emergency.

“Now the US is facing a shortage of oseltamivir and we have informed our readiness to supply the drug if needed,” said the Cipla’s chairman and managing director, Y K Hamied.

Hetero Drugs reportedly launched oseltamivir syrup in October. Hetero’s Fluvir syrup costs Rs 520 for a bottle containing of 75 ml of oseltamivir, reports said quoting chemists’ association sources of Pune District.

Hetero Drugs, which launched oseltamivir under brand name Fluvir in India, produces the H1N1 swine drug under the sub licence from Roche which it signed in 2005.

Hetero Drug has supplied the first stock of Fluvir (oseltamivir) paediatric syrup Oseltamivir for private sale across the 12 designated chemists’ shops having schedule X licence in Pune, Maharashtra, reports said.

Natco Pharma is also learnt to be in race to launch as pediatric syrup version of its generic oseltamivir brand Natflu.

Recently, the government has lifted a ban on the sale of oseltamivir and zanamivir through retail chemists.

Oseltmivir to treat H1N1 swine flu has been restricted through government health centres till 15th September, as a measure to prevent random of the drugs the possibility of developing resistance to these two drugs –one of the two available options to treat swine flu.

Earlier, India government had procured around 9 million doses of oseltamivir from Hetero Drugs, the only domestic company that has a manufacturing agreement with Roche to make the low cost version of the patented version.

On september 1, Daiichi Ranbaxy Laboratories got orders from the Centre to supply 900,000 doses of oseltamivir- the generic version of Roche’s anti-viral Tamiflu – used to treat the H1N1 flu, a Ranbaxy spokesman said.

Bangalore-based Strides Arcolab also bagged a contract order from the Ministry of Health, Government of India for supply of 7.40 lakh doses of oseltamivir capsules, a day ago to tackle the emergency situation arising out of H1N1 pandemic outbreak in the country, as part of its second round of oseltmavir procurement to bolster the drug stockpile.

The health ministry also gave order to Roche for another one million doses of oseltamivir to complete its 10 million doses drug reserve.

The government is procuring oseltamivir at around Rs 280 for a pack of 10 tablets.