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) Dienogest||2 mg Tablet||Vinca||Embil International Philippines, Inc.|
|2) Medroxyprogesterone||150 mg/mL Suspension for Injection (IM)||Medroxin||Endure Medical, 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].