Share this Post!

In compliance with Republic Act No. 10354, also known as “The Responsible Parenthood and Reproductive Health Act of 2012” and its IRR, the Food and Drug Administration (FDA) hereby invites all concerned to submit their petitions and any corresponding evidence on the mechanism of action of the following contraceptive products within ten (10) calendar days from the posting of this Advisory:

 

Generic Name Dosage Strength and Form Brand Name Marketing Authorization Holder (MAH)
1)      Drospirenone + Ethinylestradiol 3 mg/30 mcg Tablet Yanci-30 Mylan Philippines, Inc.
2)      Drospirenone + Ethinylestradiol 3 mg/20 mcg Tablet Yanci-20 Mylan Philippines, Inc.
3)      Cyproterone acetate + Ethinylestradiol 2 mg/35 mcg Tablet Cypress Mylan Philippines, Inc.
4)      Drospirenone + Ethinylestradiol 3 mg/20 mcg Tablet Warda Atlantic Pharmaceuticals, Inc.
5)      Desogestrel 75 mg Tablet Desogest Atlantic Pharmaceuticals, Inc.
6)      Ethinylestradiol + Levonorgestrel; Ferrous Fumarate 30 mcg/125 mcg/75 mg Tablet Trust Pill DKT Health Inc.
7)      Drospirenone 4 mg Film-Coated Tablet Slinda Exeltis Philippines, Inc.
8)      Medroxyprogesterone acetate 150 mg/mL Suspension for Injection (IM) Medwin Medethix, Inc.
9)      Medroxyprogesterone acetate 150 mg/mL Suspension for Injection (IM) None Medethix, Inc.
10)   Medroxyprogesterone acetate 150 mg/mL Pre-Filled Syringe Medwin Medethix, Inc.
11)   Medroxyprogesterone acetate 150 mg/mL Suspension for Injection (IM) None Medethix, Inc.
12)   Medroxyprogesterone acetate 150 mg/mL Pre-Filled Syringe None Medethix, Inc.
13)   Medroxyprogesterone acetate 150 mg/mL Suspension for Injection (IM) Dimple S.M.H.P. Marketing & Consultancy
14)   Levonorgestrel 30 mcg Film-Coated Tablet Famy-Pop Mylan Philippines, Inc.
15)   Levonorgestrel + Estradiol + Ferrous Fumarate 150 mcg/30 mcg/75 mg Tablet Zinnia F Mylan Philippines, Inc.

 

Documents and scientific evidence can be submitted to the Food and Drug Action Center (FDAC), 3rd Floor Starmall, Alabang, Muntinlupa on Mondays to Fridays, 8:00 am to 5:00 pm or email to [email protected].

Attachment:-> FDA-Advisory-No.2021-0186