Category: Drugs Announcements

Media Announcement of Seapharma International, Inc. on the Recall of Affected Batches of Enalapril Maleate 10 mg and 20 mg Tablets (Prilsea 10 & Prilsea 20)

SUMMARY

Reason for Announcement: Out-of-Specification (Failed Assay) in the Laboratory Analyses
Marketing Authorization Holder (MAH): Seapharma International, Inc.
Product Description: Enalapril Maleate 10 mg and 20 mg Tablets (Prilsea 10 & Prilsea 20)
Registration Number: DRP-6090 & DR-XY44331

The stated MAH released their media announcement (see attached) on their voluntary recall of the aforementioned drug products. The said press release was also uploaded in their official website/account at https://www.facebook.com/112180080343640/posts/114987580062890/?d=n.

For more information and inquiries, please e-mail us at [email protected]. To inform us on the continuous sale or distribution of recalled health products, kindly report through the online reporting facility, eReport, at http://www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> Media Announcement-Prilsea 10 and Prilsea 20

/ In Drugs Announcements / By Administrator / Comments Off on Media Announcement of Seapharma International, Inc. on the Recall of Affected Batches of Enalapril Maleate 10 mg and 20 mg Tablets (Prilsea 10 & Prilsea 20)

List of Authorized Biosimilars (as of 1 January 2019)

The first regulation on pharmaceuticals was in 1989 this include registration of vaccines. In 2001 the specific regulation of vaccines and biological products was signed into law, this provides guidance on how to register vaccines and biologicals in the country. Through the years we have seen a number of developments and innovations in the field of biologicals. However, their cost has often been high which limits the access of patients in developing countries. The expiration of patents of innovative biological products has ushered in a new phase in biological product development in which a product may be considered “similar” to the innovator. This resulted in the issuance of guidelines on “biosimilar” or “similar biotherapeutic” products in 2014.

Since then the FDA has licensed four (4) biosimilar products namely:

  • Insulin Glargine (Basaglar) 100 IU / mL
  • Insulin Glargine (Basaglar Kwikpen) 100 IU / mL
  • Filgrastim (Zarzio) 30 MU / 0.5 mL
  • Rituximab (Truxima) 500mg / 50 mL
No. COMPANY REGISTRATION NUMBER ACTIVE SUBSTANCE BRAND NAME PHARMACOLOGIC CATEGORY STRENGTH FORM MANUFACTURER PACKAGING
1 ELI LILLY (PHILIPPINES), INC. BRP-058 Insulin Glargine Basaglar Antidiabetic 100 Units/mL Solution for Injection (SC) Lilly, France 3 mL solution in a cartridge (type I colourless glass) with a plunger (chlorobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutyl rubber) with aluminum seal. Box of 1’s and 5’s.
2 ELI LILLY (PHILIPPINES), INC. BRP-059 Insulin Glargine Basaglar Kwikpen Antidiabetic 100 Units/ mL Solution for Injection (SC) Lilly, France 3 mL solution in a cartridge (type I colourless glass) with a plunger (chlorobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutyl rubber) with aluminum seal. Box of 1’s and 5’s.
3 Sandoz Philippines Corporation BR-1198 Filgrastim Zarzio Immunostimulant, colony stimulating factor 30 MU/0.5mL Solution for Injection / Infusion IDT Biologika GmbH, Germany Pre-filled syringe (type I glass) with injection needle (stainless steel), with a needle safety guard, containing 0.5mL solution (box of 5’s)
4 Celltrion Healthcare Philippines Inc. BR-083 Rituximab Truxima Antineoplastic 500 mg/50 mL Concentrate for Solution  for Infusion Celltrion Incorporated (Plant 2), Korea 50 mL Type I borosilicate glass vial with rubber stopper and flip-off seal (Box of 1’s)

CDRR Officers of the Day for 9-11 and 13 December 2019

In view of the Performance Review and other FDA activities scheduled on 9-11,13 December-2019, please be- informed that there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC).

We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. Walk-in clients may also opt to approach the Public Assistance desk located in the FDAC.

For your information and guidance.

Attachment:->CDRR Officers of the Day for 9-11 and 13 December 2019

 

children birthday backdrops/birthday backdrops for photography/backdrop for boys birthday party

#MedSafetyWeek (28 November 2019)

New problems in a patient on multiple medications may be side effects or interactions. Is your patient taking too many products? Review their prescriptions and report any side effects:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

#MedSafetyWeek
#PhFDA

#MedSafetyWeek (27 November 2019)

Sometimes you need to take more than one medicine for long-term or complex conditions. Be vigilant about side effects! Report them here:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

#MedSafetyWeek
#PhFDA

#MedSafetyWeek (26 November 2019)

Some medicines should not to be taken with other medicines or with certain foods. Always read the leaflet and report any side effects:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

#MedSafetyWeek
#PhFDA

 

CDRR Officers of the Day for 1-2 October 2019

The Center for Drug Regulation and Research (CDRR) will be Having its Operational Planning on 1-2 October 2019. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC).

We advise our clients to kindly send all queries and concerns via [email protected] and we will respond accordingly.

For your information and guidance.

National Consciousness Week Against Counterfeit Medicines 2019

Heads Up Poster Makers!

Be part of the National Consciousness Week Against Counterfeit Medicines 2019 Poster Making Contest with a THEME:

” PAMBANSANG REGULASYON PAGTIBAYIN, PEKENG GAMOT SUGPUIN “

For the Registration Form, kindly download the attachment below…

Attachment-> : Registration Form

CDRR Officers of the Day for 17-19 July 2019

The Center for Drug Regulation and Research (CDRR) will be having its Operational Planning on 17-19 July 2019. In line with this, there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC).

We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly.

For your information and guidance.

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