FDA grants EUA for anti-Covid pill

The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to an anti-Covid pill which was first used in select health facilities through compassionate special permit (CSP).

In a televised Laging Handa public briefing Thursday, FDA Director General Eric Domingo said the antiviral molnupiravir with a brand name Molnarz may now be taken by adults 18 years old and above with mild to moderate symptoms of Covid-19 and those at risk of developing severe illnesses like senior citizens and individuals with comorbidities.

“It comes in 200 milligram capsules…hindi po ito puwede sa mga severe o iyong mga nangangailangan na ng oxygen (this is not for patients with severe symptoms or needing oxygen),” he added.

The pill may be given twice a day – 800 milligrams – for five days within the first onset of symptoms. Otherwise, it would not be useful for the patients.

It is not recommended for pregnant and lactating women because data on its safety for this group of patients are still unavailable.

While the FDA will no longer issue CSPs for the use of molnupiravir, it reminded hospitals that have stocks of the drug to still observe the guidelines on the procurement, distribution, and rationale drug use of Covid-19 drugs under EUA.

“Dahil hindi pa naman po ito CPR [Certificate of Product Registration] or full registration na maaari siyang commercially available, ito ay kailangang dumaan pa rin po sa mga (Because this is not yet CPR or full registration where it can be made commercially available. This has to go through the) rules and regulations ng Department of Health,” Domingo said.

Source: Philippines News Agency

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