FDA permanently revokes Dengvaxia’s certificate of registration

admin   •   February 19, 2019   •   2332

FILE PHOTO: The controversial dengue vaccine, Dengvaxia

The Food and Drug Administration has permanently revoked anti-dengue vaccine Dengvaxia’s certificates of product registration (CPR) due to the continued failure of manufacturer, Sanofi Pasteur Inc. to submit post-approval commitment documents.

FDA Director General Nela Charade Puno on Tuesday cited in a statement the French pharmaceutical firm’s disregard of the agency’s rules and regulations as reason for its CPRs’ cancellation.

“Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” Puno said.

The revocation of the Dengvaxia’s CPR makes its importation, sale and distribution illegal in the Philippines, according to the FDA.

Dengvaxia’s CPR was initially suspended for a year since December 29, 2017 after Sanofi’s failure to comply with post-marketing requirements.

Prior to the lapse of the one-year suspension on December 17, 2018, Sanofi failed to comply with post-marketing authorization requirements. The company has since then suspended the sale and marketing of the vaccine. — Robie de Guzman

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DOH agrees with FDA decision to ban Dengvaxia in Phl

Maris Federez   •   August 22, 2019

A Filipino nurse prepares to administer an anti-dengue vaccine during a nationwide vaccination at a school in the flood-prone city of Marikina, east of Manila, Philippines, 04 April 2016. (Photoville International / FILE)

The Department of Health (DOH) has rejected the request of Sanofi Pasteur to overturn the decision of the Food and Drug Administration (FDA) to ban the use of Dengvaxia vaccine in the Philippines.

With this, the DOH approved the ruling of the FDA to permanently revoke the certificate of product registration of Dengvaxia for Sanofi’s failure to submit the necessary post-approval requirements.

“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” DOH Secretary Francisco Duque III said in a statement.

Although Sanofi was able to submit the first two versions of its risk management plans (RMP), the pharmaceutical company failed to submit the third and final version of the plan.

The DOH said, however, that Sanofi may apply for a new certificate of product registration (CPR) for Dengvaxia but this must be in accordance with the FDA regulations.

“Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” the statement added.

Meanwhile, the department has assured that it continues to address the increasing cases of dengue in the country. /mbmf

FDA eyes restricting sale of flavored e-cigarettes

Aileen Cerrudo   •   August 21, 2019

FILE PHOTO: Jerred Marsh (R) samples flavored vape juice from Nancy Reyes at the Vape Summit 3 in Las Vegas, Nevada May 2, 2015. REUTERS/David Becker/File Photo

The Food and Drug Administration (FDA) has recommended to the 18th Congress to limit the sale of flavored e-cigarettes.

Officer in Charge, Food and Drug Administration Usec. Eric Domingo said this is to prevent children from trying vaping.

Domingo said because of these flavors, the children might think it is safe to consume.

“Of course dapat hindi siya attractive to minors. Gusto natin wala iyong mga flavor na candy, flavor na minsan cheesecake. Hindi ba ganiyan iyong mga flavor nila which attract children(Of course it should not be attractive to minors. We do not want the candy flavor, or the cheesecake flavor. Aren’t those flavors very attractive to children?),” he said.

READ: House OKs tax hike on alcohol, vape products on third reading

The FDA also said that one of the most effective ways to prevent the youth from doing vices is to increase its taxes.

The House of Representatives already approved the excise tax hike on alcohol and vape products on the third reading.

Vape PH, meanwhile, said that higher taxes can only force people to go back to smoking.

“Heavy taxes on reduced-risk products will only result in smokers sticking it out with conventional cigarettes instead of switching to less harmful nicotine products,” their statement reads.

The Philippine E-Cigarette Industry Association (PECIA) said there was no public consultation for the proposed bill.

“Our organization could have provided the resources and studies to aid House Representatives understand tobacco harm reduction strategies being embraced by some countries,” according to their statement.—AAC (with reports from Mai Bermudez)

Batch of Similac Tummicare One Infant Formula recalled over label, scoop difference – FDA

Robie de Guzman   •   August 16, 2019

📷 FDA Facebook page

MANILA, Philippines – Abbot Laboratories, the maker of One Infant Formula, Similac Tummicare, has voluntarily recalled a batch of the product due to differences in the label instructions and scoop size, the Food and Drugs Administration (FDA) said.

In an advisory, the FDA said the 820-gram packs of Similac Tummicare with batch no. 03518QU, manufacturing date of March 2019 and expiration date of March 2022 “contained a smaller red preparation scoop compared to the white preparation scoop that is shown on the label instructions.”

Abbot Laboratories was prompted to issue a recall order after receiving an inquiry from a customer regarding the consistency.

“The product is safe to consume, however, if the red scoop is used to prepare the formula according to the label instructions and provided to an infant as a sole source of nutrition, it would not provide sufficient nutrition to support normal growth,” the FDA said in an advisory issued Wednesday.

Although Abbott Laboratories has not received any adverse events from the incident, the company “has decided to proceed with caution and voluntarily recalled the product from the market.”

The firm also clarified that the recall applies only to the product with batch no. 03518QU and no other Abbott Laboratories products are affected by this recall.

For information on how to obtain either a replacement product or full refund, consumers are advised to contact Abbott Laboratories hotline at telephone no. (02) 995-1555 (Manila) or 1800-10-995-1555 (Province) or email familyties.ph@abbott.com.

The public may also email the FDA at info@fda.gov.ph for any question or additional information regarding the recall.

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