First-Time Generic Drug Approvals for 2018
January
- Potassium Chloride Extended-Release Tablets USP, 10 mEq (750 mg) and 20 mEq (1500 mg)
Approved: January 12, 2018 - Paddock Laboratories, LLC
Generic for: K-Tab - Remifentanil Hydrochloride Injection 1 mg base/vial, 2 mg base/vial and 5mg base/vial
Approved: January 16, 2018 - Fresenius Kabi USA, LLC
Generic for: Ultiva - Levocetirizine Dihydrochloride Tablets USP, 5 mg
Approved: January 19, 2018 - Dr. Reddy’s Laboratories Limited
Generic for: Xyzal Allergy 24HR - Tenofovir Disoproxil Fumarate Tablets 150 mg, 200 mg and 250 mg
Approved: January 26, 2018 - Aurobindo Pharma Limited; Teva Pharmaceuticals USA, Inc.
Generic for: Viread 150 mg, 200 mg and 250 mg
February
- Trientine Hydrochloride Capsules 250mg
Approved: February 7, 2018 - Actavis Pharma, Inc.
Generic for: Syprine - Sumatriptan Succinate and Naproxen Sodium Tablets 85mg (base)/ 500mg (base)
Approved: February 15, 2018 - Aurobindo Pharma Limited
Generic for: Treximet
March
- Cinacalcet Hydrochloride Tablets 30 mg (base), 60 mg (base), and 90 mg (base)
Approved: March 8, 2018 - Cipla Ltd.; Aurobindo Pharma Limited
Generic for: Sensipar
April
- Everolimus Tablets 0.25 mg, 0.5 mg and 0.75 mg
Approved: April 12, 2018 - West-Ward Pharmaceuticals Corp.
Generic for: Zortress - Ertapenem Sodium for Injection 1 gram (base)/vial
Approved: April 16, 2018 - ACS Dobfar S.p.A.
Generic for: Invanz - Miglustat Capsules 100 mg
Approved: April 17, 2018 - Amerigen Pharmaceuticals, Inc.
Generic for: Zavesca - Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL and 100 mg/10 mL
Approved: April 27, 2018 - Cipla USA Inc.
Generic for: Vazculep
May
- Phytonadione Tablets 5 mg
Approved: May 11, 2018 - Amneal Pharmaceuticals LLC
Generic for: Mephyton - Colesevelam Hydrochloride Tablets 625mg
Approved: May 16, 2018 - Impax Laboratories, Inc.
Generic for: Welchol - Methylphenidate Hydrochloride for Extended Release Oral Suspension 5 mg/mL
Approved: May 17, 2018 - Actavis Pharma, Inc.
Generic for: Quillivant XR - Tadalafil Tablets 2.5mg, 5mg, 10mg and 20mg
Approved: May 22, 2018 - Teva Pharmaceuticals USA, Inc.
Generic for: Cialis - Oxybutynin Chloride Transdermal Gel 10% (100mg/packet)
Approved: May 31, 2018 - Par Pharmaceutical, Inc.
Generic for: Gelnique
June
- Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/ 3.75%
Approved: June 5, 2018 - Taro Pharmaceuticals Inc.
Generic for: Onexton - Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film 2 mg/0.5 mg, 8 mg/2 mg, 4 mg/1 mg and 12 mg/3 mg
Approved: June 14, 2018 - Dr. Reddy's Laboratories SA; Mylan Technologies Inc. (8 mg/2 mg and 12 mg/3 mg only)
Generic for: Suboxone Sublingual Film
July
- Emtricitabine Capsules 200 mg
Approved: July 2, 2018 - Cipla USA Inc.
Generic for: Emtriva - Budesonide Extended-Release Tablets 9 mg
Approved: July 3, 2018 - Actavis Laboratories FL, Inc.
Generic for: Uceris Extended-Release Tablets - Roflumilast Tablets 500 mcg
Approved: July 13, 2018 - Mylan Pharmaceuticals Inc.
Generic for: Daliresp - Colesevelam Hydrochloride for Oral Suspension 1.875 grams/packet and 3.75 grams/packet
Approved: July 16, 2018 - Glenmark Pharmaceuticals Inc.
Generic for: Welchol for Oral Suspension - Asenapine Maleate Sublingual Tablets 5 mg (base) and 10 mg (base)
Approved: July 17, 2018 - Sigmapharm Laboratories LLC
Generic for: Saphris - Teriflunomide Tablets 7 mg and 14 mg
Approved: July 27, 2018 - Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Generic for: Aubagio - Temsirolimus Intravenous Solution 25 mg/mL
Approved: July 30, 2018 - Accord Healthcare Inc.
Generic for: Torisel
August
- Tadalafil Tablets 20mg
Approved: August 3, 2018 - Mylan Pharmaceuticals Inc.
Generic for: Adcirca - Epinephrine (Autoinjector) Injection 0.15 mg/delivery and 0.3 mg/delivery
Approved: August 16, 2018 - Teva Pharmaceuticals USA, Inc.
Generic for: EpiPen Jr. and EpiPen - Arsenic Trioxide Injection 10 mg/10 mL Single-dose Vial
Approved: August 31, 2018 - Fresenius Kabi USA, LLC
Generic for: Trisenox
September
- Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600 mg/200 mg/300 mg
Approved: September 4, 2018 - Aurobindo Pharma Limited
Generic for: Atripla - Ticagrelor Tablets 60mg and 90mg
Approved: September 4, 2018 - Watson Laboratories, Inc.
Generic for: Brilinta - Carmustine for Injection USP, 100 mg/vial
Approved - September 11, 2018 - Navinta LLC
Generic for: BiCNU - Albendazole Tablets 200 mg
Approved: September 21, 2018 - Cipla Ltd.
Generic for: Albenza
October
- Cefixime Capsules 400 mg
Approved: October 9, 2018 - Alkem Laboratories Limited
Generic for: Suprax Capsules - Adapalene and Benzoyl Peroxide Gel 0.3%/2.5%
Approved: October 17, 2018 - Taro Pharmaceuticals USA, Inc.
Generic for: Epiduo Forte - Clobazam Tablets 10 mg and 20 mg
Approved: October 22, 2018 - Amneal Pharmaceuticals LLC; Bionpharma Inc.; Breckenridge Pharmaceutical, Inc.; Camber Pharmaceuticals, Inc.; Sandoz Inc.; Taro Pharmaceuticals U.S.A., Inc.; Upsher-Smith Laboratories, LLC; West-Ward Pharmaceuticals Corp.; Zydus Pharmaceuticals (USA) Inc.
Generic for: Onfi Tablets - Clobazam Oral Suspension 2.5 mg/mL
Approved: October 22, 2018 - Amneal Pharmaceuticals LLC; Bionpharma Inc.; Mylan Pharmaceuticals Inc.; Upsher-Smith Laboratories, LLC; West-Ward Pharmaceuticals Corp.
Generic for: Onfi Oral Suspension - Naproxen Sodium and Diphenhydramine Hydrochloride Tablets 220mg/25mg
Approved: October 23, 2018 - Amneal Pharmaceuticals LLC
Generic for: Aleve PM - Abiraterone Acetate Tablets 250 mg
Approved: October 31, 2018 - Apotex, Inc.; Hikma Pharmaceuticals LLC; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.
Generic for: Zytiga 250 mg
November
- Vardenafil Hydrochloride Orally Disintegrating Tablets 10 mg
Approved: November 16, 2018 - Alembic Pharmaceuticals Ltd.
Generic for: Staxyn - Azelaic Acid Topical Gel 15%
Approved: November 19, 2018 - Actavis Laboratories UT Inc.; Glenmark Pharmaceuticals; Tolmar Inc.
Generic for: Finacea Gel - Docosanol Cream 10%
Approved: November 19, 2018 - Actavis Laboratories UT, Inc.
Generic for: Abreva - Buprenorphine Transdermal System 5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour
Approved: November 20, 2018 - Watson Laboratories, Inc.
Generic for: Butrans - Colchicine Capsules 0.6 mg
Approved: November 29, 2018 - Par Pharmaceutical Inc.
Generic for: Mitigare - Bismuth Subsalicylate, Metronidazole and Tetracycline Hydrochloride Chewable Tablets 262.4 mg / Tablets 250 mg / Capsules 500 mg
Approved: November 30, 2018 - Ailex Pharmaceuticals LLC
Generic for: Helidac
December
- Toremifene Citrate Tablets 60 mg (base)
Approved: December 4, 2018 - Eirgen Pharma Ltd.
Generic for: Fareston - Pimecrolimus Topical Cream 1%
Approved: December 27, 2018 - Actavis Laboratories UT, Inc.
Generic for: Elidel