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FDA Advisory No. 2018-195

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)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Ridne-35 Hyphens Pharma Philippines Inc.
2)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Film-Coated Tablet Ethidol-C Ambica International Corporation
3)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Estelle-35D Zuellig Pharma Corporation
4)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Film-Coated Tablet Safex A.T.C. Health Care Int’l Corp.
5)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Diane 35 Bayer Philippines Inc.
6)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Ariane Innogen Pharmaceuticals, Inc.
7)      Cyproterone acetate + Ethinylestradiol 2mg / 35mcg Tablet Faye AAA Pharma, Inc.
8)      Cyproterone acetate + Estradiol valerate 2mg / 1mg Tablet Climen 28 Bayer Philippines Inc.
9)      Desogestrel 75 mcg Tablet Andrea DKT Health, Inc.
10)   Desogestrel 75 mcg Film-Coated Tablet Desirett Exeltis Philippines Inc.
11)   Desogestrel + Ethinylestradiol 150mcg / 30mcg Tablet Daisy-30 S.M.H.P. Marketing & Consultancy
12)   Desogestrel + Ethinylestradiol 150mcg / 30mcg Film-Coated Tablet Mariona Exeltis Philippines Inc.
13)   Dienogest 2 mg Tablet Vinca Chemway Pharma, Inc.
14)   Drospirenone + Ethinylestradiol 3mg / 20mcg Tablet Gvez Metro Drug, Inc.
15)   Drospirenone + Ethinylestradiol 3mg / 30mcg Film-Coated Tablet Gveza Metro Drug, Inc.
16)   Drospirenone + Ethinylestradiol 3mg / 30mcg Tablet Erin DKT Health, Inc.
17)   Estradiol + Drospirenone 2mg / 1mg Tablet Angeliq Bayer Philippines, Inc.
18)   Levonorgestrel 1.5 mg Film-Coated Tablet Co-Pill Ambica International Corporation
19)   Levonorgestrel 1.5 mg Film-Coated Tablet Gestrex Next Chemical Enterprises
20)   Levonorgestrel 750 mcg Tablet Lenor-72 Ambica International Corporation
21)   Levonorgestrel 30 mcg Tablet Safex Golden Dale Pharma Corp.
22)   Levonorgestrel 1.5 mg Tablet Levonia One Bonamis Pharmacy Philippines Corporation
23)   Levonorgestrel 750 mcg Tablet Contra 72 Pharmastar Int’l Trading Corporation
24)   Levonorgestrel + Ethinylestradiol 20mg/mL Tablet Aecys Fresenius Kabi Philippines Inc.
25)   Levonorgestrel + Ethinylestradiol 150 mcg / 30 mcg Sugar-Coated Tablet Zinnia P S.M.H.P. Marketing & Consultancy
26)   Levonorgestrel + Ethinylestradiol 250mcg / 50mcg Film-Coated Tablet Florina-G Ambica International Corporation
27)   Levonorgestrel + Ethinylestradiol 150mcg / 30mcg Tablet Besafe AAA Pharma, Inc.
28)   Levonorgestrel + Ethinylestradiol 150mcg / 30mcg Film-Coated Tablet Meleva Chemway Pharma, Inc.
29)   Levonorgestrel + Ethinylestradiol 150mcg / 30mcg Film-Coated Tablet Florina Ambica International Corporation
30)   Levonorgestrel + Ethinylestradiol 150mcg / 30mcg Tablet Conchoice Sun Pharma Philippines Inc.
31)   Levonorgestrel + Ethinylestradiol 250mcg / 50mcg Tablet Conchoice Plus Sun Pharma Philippines Inc.
32)   Levonorgestrel + Ethinylestradiol + Ferrous fumarate 125mcg / 30mcg; 75mcg Film-Coated Tablet Safex-Combi Golden Dale Pharma Corporation
33)   Levonorgestrel + Ethinylestradiol + Ferrous fumarate 150mcg / 30mcg / 75mg Film-Coated Tablet Helena Plus Eon Pharmatek, Inc.
34)   Medroxyprogesterone acetate 150 mg/mL Injection Famy-Depo S.M.H.P. Marketing & Consultancy
35)   Medroxyprogesterone acetate 50 mg/mL Suspension for Injection (I.M.) Contracep Healol Pharma Corporation
36)   Medroxyprogesterone acetate Sterile Aqueous Suspension for Injection Depo-Provera Pfizer, Inc.
37)   Medroxyprogesterone acetate 104mg / 0.65mL Suspension for Injection Sayana Press Pfizer, Inc.
38)   Medroxyprogesterone acetate 150 mg/mL Sterile Aqueous Suspension for Injection (I.M.) Femme-3 Amtol Pharma Imports Inc.
39)   Medroxyprogesterone acetate 50 mg/mL (150mg / 3mL) Solution for Injection (I.M.) Provestin Phil Pharmawealth, Inc.
40)   Medroxyprogesterone acetate 10 mg Tablet Deporeva QB International Trade
41)   Medroxyprogesterone acetate 10 mg Tablet Xygyn Ambica International Corporation
42)   Medroxyprogesterone acetate 150 mg/mL Daisy-30 S.M.H.P. Marketing & Consultancy
43)   Lynestrenol 500 mcg Tablet None DKT Health, Inc.
44)   Norethisterone 5 mg Tablet None Ambica International Corporation
45)   Norethisterone 5 mg Tablet Steron Ambica International Corporation
46)   Norethisterone 5 mg Tablet NCnorm-P Ambica International Corporation
47)   Norethisterone + Ethinylestradiol 400mcg / 35mcg None Lloyd Laboratories, Inc.
48)   Norgestrel + Ethinylestradiol 500mcg / 50mcg Film-Coated Florina-N Ambica International Corporation
49)   Intra Uterine Contraceptive Device, Code: TCu 380A N/A Eve’s AAA Pharma, Inc.
50)   Intrauterine Contraceptive Device N/A Pregna DKT Philippines, Inc.

 

Documents and scientific evidence can be submitted to the Food and Drug Action Center (FDAC), Civic Drive, Filinvest City, Alabang, Muntinlupa on Mondays to Fridays, 8:00 am to 5:00 pm.