Advisories

FDA Advisory No. 2017-302 || RESULTS OF THE FOOD AND DRUG ADMINISTRATION’S (FDA) RE-EVALUATION OF CONTRACEPTIVE PRODUCTS FOR RECERTIFICATION

FDA Advisory No. 2017-302

RESULTS OF THE FOOD AND DRUG ADMINISTRATION’S (FDA) RE-EVALUATION OF CONTRACEPTIVE PRODUCTS FOR RECERTIFICATION

The FDA has concluded the re-evaluation of the following contraceptive products:

No.

Generic Name

Dosage Strength and Form

Brand Name

Registration No.

1. 

Desogestrel

75 mg Tablet

Cerazette

DR-XY27146

2. 

Desogestrel

75 mcg Tablet

Estrelle

DR-XY40817

3. 

Lynestrenol

500 mcg Tablet

Exluton

DR-XY18077

4. 

Lynestrenol

500 mcg Tablet

Daphne

DRP-2088

5. 

Lynestrenol

500 mcg Tablet

Leila

DRP-2138

6. 

Etonogestrel

68 mg Subdermal Implant

Implanon

DR-XY27500

7. 

Etonogestrel

68 mg Subdermal Implant

Implanon NXT

DR-XY41412

8. 

Medroxyprogesterone acetate

50 mg/ mL Suspension for Injection (IM)

Depo-gestin

DR-XY39023

9. 

Medroxyprogesterone acetate

150 mg/mL Suspension for Injection (IM)

Depo-gestin

DRP-3643

10.               

Medroxyprogesterone acetate

150mg/ml Suspension for IM

Depofemme

DR-XY40409

11.               

Medroxyprogesterone acetate

50mg/ml Suspension for IM

Depotrust

DR-XY34137

12.               

Medroxyprogesterone acetate

150 mg/mL Suspension for Injection (IM/SC)

Lyndavel

DRP-338

13.               

Medroxyprogesterone acetate

150 mg/mL Suspension for Injection (IM/SC)

None

DR- XY30830

14.               

Medroxyprogesterone Acetate

150 mg/mL Suspension for Injection (I.M.)

Protec

DR-XY42049

15.               

Medroxyprogesterone acetate

50mg/ml Suspension for IM

Depotrust

DRP-363

16.               

Levonorgestrel

52 mg (20 mcg/24 hours) Intrauterine Delivery System

Mirena

DR-XY25174

17.               

Cyproterone acetate+ Ethinylestradiol

2mg/ 35 mcg Tablet

Chloe

DRP-2496

18.               

Cyproterone acetate+ Ethinylestradiol

2mg/ 35 mcg Tablet

Althea

DRP-339

19.               

Cyproterone acetate+ Ethinylestradiol

2mg/ 35 mcg Tablet

Cybelle

DRP-4439

20.               

Desogestrel + Ethinylestradiol

150 mcg/20 mcg Tablet

Estrelle Plus

DR-XY40787

21.               

Desogestrel+ Ethinylestradiol

150 mcg/ 20 mcg Tablet

Mercilon

DR-XY21633

22.               

Desogestrel+ Ethinylestradiol

150 mcg/ 30 mcg Tablet

Marvelon 28

DR-XY2299

23.               

Desogestrel+ Ethinylestradiol

125 mcg/ 30 mcg Tablet

Gracial

DR-XY26961

24.               

Drospirenone+ Ethinylestradiol

3mg/ 30 mcg Tablet

Liza

DRP-3751

25.               

Drospirenone+ Ethinylestradiol

3mg/20mcg FC Tablet

Lizonya

DRP-3750

26.               

Drospirenone+ Ethinylestradiol

3mg/ 30 mcg Tablet

Yasmin

DR-XY28181

27.               

Drospirenone+ Ethinylestradiol

3mg/20mcg FC Tablet

Lizelle

DRP-4625

28.               

Drospirenone+ Ethinylestradiol

3mg/20mcg FC Tablet

Yaz

DR-XY34970

29.               

Estradiol Valerate + Dienogest

Film-Coated Tablet

Qlaira

DR-XY38455

30.               

Gestodene+ Ethinylestradiol

75 mcg/ 30 mcg Tablet

Sophia

DRP-2802

31.               

Gestodene+ Ethinylestradiol

75 mcg/ 20 mcg Tablet

Meliane

DR-XY25428

32.               

Gestodene+ Ethinylestradiol

75 mcg/ 30 mcg Tablet

Gynera

DR-XY25163

33.               

Levonorgestrel + Ethinylestradiol

151 mcg/ 30 mcg Tablet

Julianne

DRP-4297

34.               

Levonorgestrel + Ethinylestradiol

153 mcg/ 30 mcg Tablet

Nordette

DR-XY23241

35.               

Levonorgestrel + Ethinylestradiol

152 mcg/ 30 mcg Tablet

Lady

DRP-337

36.               

Levonorgestrel + Ethinylestradiol

125 mcg/ 30 mcg Tablet

Denise

DR-XY40669

37.               

Levonorgestrel + Ethinylestradiol

100 mcg/ 20 mcg FC Tablet

Minipil

DRP-3738

38.               

Levonorgestrel + Ethinylestradiol

150 mcg/ 30 mcg Tablet

Seif

DR-XY8804

39.               

Levonorgestrel + Ethinylestradiol

50 mcg/ 30 mcg Tablet

Logynon 21

DR-XY9421

40.               

Levonorgestrel + Ethinylestradiol; Ferrous Fumarate

150 mcg/ 30 mcg/ 60 mg Tablet

Protec

DR-XY38297

41.               

Levonorgestrel + Ethinylestradiol; Ferrous Fumarate

150 mcg/ 30 mcg/ 75 mg Tablet

Famila 28F

DR-XY35393

42.               

Levonorgestrel+ Ethinylestradiol + Ferrous fumarate

150 mcg/ 30 mcg /60 mg Tablet

Femme

DR-XY-37779

43.               

Levonorgestrel+ Ethinylestradiol + Ferrous fumarate

125 mcg/ 30 mcg/ 75 mg Tablet

Ruby

DRP-2162

44.               

Levonorgestrel+ Ethinylestradiol + Ferrous fumarate

125 mcg/ 30 mcg/ 75 mg Tablet

Trust Pill

DRP-336

45.               

Levonorgestrel+ Ethinylestradiol + Ferrous fumarate

150 mcg/ 30 mcg/ 75 mg Tablet

Charlize

DRP-2063

46.               

Nomegestrol acetate+ Estradiol (as hemihydrate)

2.5 mg/ 1.5 mg FC Tablet

Zoely

DR-XY43109

47.               

Norethisterone+ Ethinylestradiol

400 mcg/ 35 mcg Tablet

Micropil

DR-7745

48.               

Norethisterone+ Ethinylestradiol+ Ferrous fumarate

400 mcg/ 35 mcg/ 75 mg Tablet

Micropil Plus

DR-XY34401

49.               

Norethisterone Enanthate +  Estradiol  Valerate

50 mg/ 5 mg per mL Solution for Injection (I.M)

NORIFAM

DR-XY35422

50.               

Etonogestrel+ Ethinylestradiol

11.7 mg/ 2.7 mg Controlled Release Vaginal ring

Nuvaring

DR-XY30809

51.               

Copper Intrauterine Device

Not applicable

Securit-T

DVR-7641

Per the FDA’s Resolutions dated 10 November 2017 (on the applications for recertification filed by the Market Authorization Holders [MAHs] with opposition filed by Alliance for the Family Foundation, Philippines, Inc. [ALFI]), the foregoing contraceptive products have been determined to be NON-ABORTIFACIENT.

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