FDA tests 13 new contraceptives

MANILA, Philippines — Thirteen new contraceptive products are now the subjects of the certification process of the Food and Drug Administration (FDA) to make sure that they are non-abortifacient.

According to FDA director general Rolando Enrique Domingo, the products are not included in the 51 contraceptives earlier re-certified as non-abortifacient and does not cause abortion.

In FDA Advisory No. 2019-256 dated Aug. 16, the agency has invited all concerned to submit their “petitions and any corresponding evidence on the mechanism of action” of the 13 products.  It was posted on the agency’s Facebook account last Aug. 29.

The new products are:

Chlormadinone acetate + Ethinlestradiol 2mg + 30mcg film-coated tablet, with Pharma Asia-Cuvest, Inc as marketing Authorization holder. (MHI)  (brand name: Belara)

Levonorgestrel+Ethinylestradiol  150 mcg/ 30 mcg tablet; Endure Medical Inc. as MHI (brand name: none)

Lynestrenol  500 mcg tablet, with Endure Medical Inc. as MHI (Lyndel)

Medroxyprogesterone acetate   50 mg/mL suspension for injection (IM); DKT Health Inc. (Trust MI Injectable)

Medroxyprogesterone acetate    50 mg/mL suspension for injection (IM) DKT Health Inc. (Trust 3M1 injectable)

Medroxyprogesterone acetate + Estradiol Cypionate  25mg/0.5 mL + 5 mg/0.5 mL suspension for injection (IM); DKT Health Inc. (Trust One-month injectable)

Levonorgestrel   75mg subdermal implant; Bayer Philippines Inc. (Jadelle)

Norethisterone    5mg tablet; Bayer Philippines (Primolut N)

Drospirenon + Ethinylestradiol  3 mg+ 20 mcg film-coated tablet;  Sun Pharma Philippines Inc. (Dronis) 

Drospirenon + Ethinylestradiol   3 mg +30 mcg film-coated tablet; Sun Pharma Philippines Inc. (Drospill)

Cyproterone acetate + Ethinylestradiol   2mg + 35 mcg film-coated tablet;  Sun Pharma Philippines (Suncet 35) 

Levonorgestrel+Ethinylestradiol   150 mcg + 30 mcg tablet; Lloyd Laboratories (Solenn)

Drospirenon + Ethinylestradiol  30 mcg + 300 mcg tablet; Atlantic Pharmaceutials Inc.
(Zahra) 

The FDA has given the public 10 days from the posting of the advisory to submit their documents and scientific evidence.

The certification of the new products is mandated by some provisions in the Responsible Parenthood and Reproductive Health Act of 2012 to ensure that the contraceptives being sold in the market are non-abortifacient.

The FDA issued on Nov. 10, 2017, Resolution 2017-310 re-certifying 51 contraceptives as non-abortifacient.

Included in the list are the controversial subdermal implants that were strongly opposed by pro-life groups.

This was in compliance with an order of the Supreme Court for the temporary restraining order issued in June 2015 to be lifted. The high tribunal was then hearing a petition filed by the Alliance for Family Foundation Philippines.

The resolution then came at a time when the country’s supply of contraceptives was about to run out due to the then 29-month old injunction order.