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