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FDA approves molnupiravir shelf life extension

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The shelf life of the anti-Covid-19 drug molnupiravir has been extended from six months to one year, according to the Food and Drug Administration (FDA).

FDA acting chief Oscar Gutierrez said the regulatory agency had approved the application of molnupiravir brands Molnarz and Monaflu for their emergency use authorization and extension of their product’s shelf life.

“We initially approved a six-month shelf life for their product. Before it expired, they submitted requirements so they were given 12 months,” Gutierrez said in his televised report to President Rodrigo Duterte’s “Talk to the People” on Monday.

“This is good news because it means that the drug would be continually imported,” he added.

Nine more firms have applied for the approval of their anti-Covid-19 drugs, as well as the extension of their drugs’ shelf lives, Gutierrez said.

At present, antiviral drugs paxlovid (nirmatrelvir and ritonavir tablets), bexovid, remdesivir, and molnupiravir may be used for the treatment of Covid-19 patients in the country.

Tocilizumab, baricitinib and dexamethasone are also used by some doctors for coronavirus medication.

The FDA cleared molnupiravir for emergency use in December last year.

Developed by American drugmaker Merck & Co. Inc., molnupiravir is considered the first oral antiviral pill for mild and moderate cases of Covid-19.

The breakthrough drug could be given only to adults 18 years old and above who are found positive for Covid-19 and with risk factors for developing severe illness, such as senior citizens and those with health conditions.

The said pill is not recommended for pregnant women and children.

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