First-Time Generic Drug Approvals for 2019
January
-
Lurasidone Hydrochloride Tablets 20 mg, 40 mg, 60 mg, 80 mg and 120 mg
Approved: January 3, 2019 - Amneal Pharmaceuticals LLC; InvaGen Pharmaceuticals Inc.; Lupin Pharmaceuticals, Inc.; Accord Healthcare Inc.; Torrent Pharmaceuticals Limited
Generic for: Latuda - Ingenol Mebutate Topical Gel 0.015%
Approved: January 7, 2019 - Perrigo
Generic for: Picato Gel 0.015% - Ingenol Mebutate Topical Gel 0.05%
Approved: January 9, 2019 - Perrigo
Generic for: Picato Gel 0.05% - Vigabatrin Tablets 500 mg
Approved: January 14, 2019 - Teva Pharmaceuticals USA, Inc.
Generic for: Sabril - Sirolimus Oral Solution 1 mg/mL
Approved: January 28, 2019 - Novitium Pharma LLC
Generic for: Rapamune Oral Solution - Wixela Inhub (fluticasone propionate and salmeterol inhalation powder) 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg
Approved: January 30, 2019 - Mylan N.V.
Generic for: Advair Diskus
February
- Acyclovir Cream 5%
Approved: February 4, 2019 - Perrigo UK Finco Limited Partnership
Generic for: Zovirax Cream - Levomilnacipran Hydrochloride Extended Release Capsules 20 mg (base), 40 mg (base), 80 mg (base) and 120 mg (base)
Approved: February 4, 2019 - Amneal Pharmaceuticals LLC
Generic for: Fetzima - Sevelamer Hydrochloride Tablets 400 mg and 800 mg
Approved: February 8, 2019 - Glenmark Pharmaceuticals Inc., USA
Generic for: Renagel - Deferiprone Tablets 500 mg
Approved: February 8, 2019 - Taro Pharmaceuticals Industries Limited
Generic for: Ferriprox Tablets - Levofloxacin Ophthalmic Solution 1.5%
Approved: February 27, 2019 - Micro Labs Limited
Generic for: Iquix
March
- Fulvestrant Injection 50mg/mL
Approved: March 4, 2019 - Amneal Pharmaceuticals LLC
Generic for: Faslodex - Bepotastine Besilate Ophthalmic Drops 1.5 %
Approved: March 5, 2019 - Apotex Corporation
Generic for: Bepreve - Pyridostigmine Bromide Syrup 60 mg/5 mL
Approved: March 8, 2019 - Novitium Pharma LLC
Generic for: Mestinon Syrup - Naftifine Hydrochloride Topical Gel 1%
Approved: March 20, 2019 - Tolmar Inc.
Generic for: Naftin Gel 1% - Aliskiren Hemifumarate Tablets 150 mg (base) and 300 mg (base)
Approved: March 22, 2019 - Anchen Pharmaceuticals, Inc.
Generic for: Tekturna - Ambrisentan Tablets 5 mg and 10 mg
Approved: March 28, 2019 - Watson Laboratories, Inc.; Mylan Pharmaceuticals Inc.; Zydus Pharmaceuticals (USA) Inc.; Sun Pharmaceutical Industries, Inc.
Generic for: Letairis
April
- Naftifine Hydrochloride Topical Gel 2%
Approved: April 10, 2019 - Taro Pharmaceuticals Inc.
Generic for: Naftin Gel 2% - Mifepristone Tablets 200 mg
Approved: April 11, 2019 - GenBioPro Inc.
Generic for: Mifeprex - Loteprednol Etabonate Ophthalmic Suspension 0.5%
Approved: April 17, 2019 - Hi-Tech Pharmacal Co., Inc.
Generic for: Lotemax Ophthalmic Suspension 0.5% - Valrubicin Intravesical Solution 40mg/mL
Approved: April 19, 2019 - Custopharm, Inc.
Generic for: Valstar - Naloxone Hydrochloride Nasal Spray 4mg/spray
Approved: April 19, 2019 - Teva Pharmaceuticals USA, Inc.
Generic for: Narcan Nasal Spray - Everolimus Tablets for Oral Suspension 2 mg, 3 mg, and 5 mg
Approved: April 19, 2019 - Mylan Pharmaceuticals, Inc.
Generic for: Afinitor Disperz - Rufinamide Oral Suspension 40mg/mL
Approved: April 23, 2019 - Bionpharma, Inc.; Hikma Pharmaceuticals USA Inc.
Generic for: Banzel Oral Suspension - Pentamidine Isethionate for Inhalation Solution 300mg/vial
Approved: April 24, 2019 - Seton Pharmaceuticals
Generic for: Nebupent - Bosentan Tablets 62.5 mg and 125 mg
Approved: April 26, 2019 - Alvogen Inc.; Amneal Pharmaceuticals LLC; Natco Pharma Ltd.; Par Pharmaceutical, Inc.; Sun Pharmaceutical Industries, Inc.; Watson Labs Inc.; West-Ward Pharmaceuticals Corp.; Zydus Pharmaceuticals (USA) Inc.
Generic for: Tracleer
May
- Penicillamine Capsules USP, 250 mg
Approved: May 7, 2019 - Amerigen Pharmaceuticals, Ltd.
Generic for: Cuprimine - Mesalamine Delayed-Release Capsules 400 mg
Approved: May 9, 2019 - Teva Pharmaceuticals USA, Inc.
Generic for: Delzicol - Sapropterin Dihydrochloride Tablets 100 mg
Approved: May 10, 2019 - Par Pharmaceutical, Inc.
Generic for: Kuvan - Micafungin Sodium Injection 50 mg (base)/vial and 100 mg (base)/vial
Approved: May 17, 2019 - Fresenius Kabi USA, LLC
Generic for: Mycamine - Sildenafil Citrate for Oral Suspension 10mg (base)/mL
Approved: May 31, 2019 - Novitium Pharma LLC
Generic for: Revatio for Oral Suspension
June
- Diclofenac Sodium Injection 37.5 mg/mL Single-Dose Vials
Approved: June 18, 2019 - Mylan Laboratories Limited
Generic for: Dyloject - Tobramycin Inhalation Solution 300 mg/4 mL (discontinued)
Approved: June 26, 2019 - Teva Pharmaceuticals USA, Inc.
Generic for: Bethkis
July
- Febuxostat Tablets 40 mg and 80 mg
Approved: July 1, 2019 - Mylan Pharmaceuticals Inc.; Alembic Pharmaceuticals Inc.; Sun Pharmaceutical Industries, Inc.
Generic for: Uloric - Ketorolac Tromethamine and Phenylephrine Hydrochloride Irrigation Solution 0.3% (base)/1% (base)
Approved: July 1, 2019 - Lupin Pharmaceuticals, Inc.
Generic for: Omidria - Carboprost Tromethamine Injection 0.25mg (base)/mL
Approved: July 2, 2019 - Dr. Reddy's Laboratories Limited
Generic for: Hemabate - Icatibant Acetate Injection 30mg base/3mL
Approved: July 15, 2019 - Teva Pharmaceuticals USA, Inc.
Generic for: Firazyr - Pregabalin Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg
Approved: July 19, 2019 - Alembic Pharmaceuticals Inc.; Alkem Laboratories Ltd.; Amneal Pharmaceuticals LLC; Dr. Reddy's Laboratories Limited; InvaGen Pharmaceuticals, Inc.; MSN Laboratories Private Ltd.; Rising Pharmaceuticals, Inc.; Sciegen Pharmaceuticals Inc.; Teva Pharmaceuticals USA, Inc.
Generic for: Lyrica Capsules - Pregabalin Oral Solution 20 mg/mL
Approved: July 19, 2019 - Alkem Laboratories Ltd.
Generic for: Lyrica Oral Solution
August
- Halcinonide Topical Cream 0.1%
Approved: August 12, 2019 - Mylan Pharmaceuticals Inc.
Generic for: Halog Cream - Levocarnitine SF Oral Solution 1 gram/10mL
Approved: August 14, 2019 - Novitium Pharma LLC
Generic for: Carnitor SF - Tafluprost Ophthalmic Solution/Drops 0.0015%
Approved: August 19, 2019 - Micro Labs Limited
Generic for: Zioptan - Sapropterin Dihydrochloride Oral Powder 100mg/packet and 500mg/packet
Approved: August 20, 2019 - Par Pharmaceutical, Inc.
Generic for: Kuvan Powder for Oral Solution - Posaconazole Delayed Release Tablets 100 mg
Approved: August 21, 2019 - Sinotherapeutics Inc.
Generic for: Noxafil Tablets - Nitisinone Capsules 2 mg, 5 mg and 10 mg
Approved: August 26, 2019 - Novitium Pharma LLC
Generic for: Orfadin Capsules
September
- Carfilzomib for Injection 60mg/vial
Approved: September 9, 2019 - Dr. Reddy's Laboratories, Inc.
Generic for: Kyprolis 60mg/vial - Ivermectin Topical Cream 1%
Approved: September 13, 2019 - Teva Pharmaceuticals USA, Inc.
Generic for: Soolantra - Vilazodone Hydrochloride Tablets 10 mg, 20 mg, and 40 mg
Approved: September 30, 2019 - Teva Pharmaceuticals USA, Inc.
Generic for: Viibryd
October
- Digoxin Oral Elixir 0.05mg/mL
Approved: October 4, 2019 - Novitium Pharma LLC
November
- Gadoterate Meglumine Injection (Clariscan) 5 mmol /10 mL, 7.5 mmol/15 mL and 10 mmol/20 mL Single-Dose Vials
Approved: November 1, 2019 - GE Healthcare Inc.
Generic for: Dotarem - Mesalamine Extended-Release Capsules, USP 0.375 g
Approved: November 1, 2019 - Mylan Pharmaceuticals Inc.
Generic for: Apriso - Deferasirox Tablets 90 mg, 180 mg and 360 mg
Approved: November 20, 2019 - Alembic Pharmaceuticals Limited; MSN Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.; Zydus Pharmaceuticals (USA), Inc.
Generic for: Jadenu
December
- Sucralfate Oral Suspension 1 gm/10mL
Approved: December 2, 2019 - Amneal Pharmaceuticals LLC
Generic for: Carafate Oral Suspension - Fingolimod Hydrochloride Capsules 0.5 mg (base)
Approved: December 4, 2019 - Biocon Pharma Inc.; HEC Pharm USA Inc.; Sun Pharmaceutical Industries, Inc.
Generic for: Gilenya - Everolimus Tablets 2.5 mg, 5 mg, 7.5 mg, and 10 mg
Approved: December 9, 2019 - Teva Pharmaceuticals USA, Inc.; Par Pharmaceutical Inc. (excl. 10 mg)
Generic for: Afinitor - Sodium Tetradecyl Sulfate Injection 60 mg/2mL
Approved: December 9, 2019 - Custopharm, Inc.
Generic for: Sotradecol - Etonogestrel and Ethinyl Estradiol Vaginal Ring (EluRyng) 0.120 mg/0.015 mg per day
Approved: December 11, 2019 - Amneal Pharmaceuticals LLC
Generic for: NuvaRing - Alvimopan Capsules 12 mg
Approved: December 19, 2019 - Watson Laboratories Inc.
Generic for: Entereg - Diazoxide Oral Suspension 50 mg/mL
Approved: December 20, 2019 - E5 Pharma Inc.
Generic for: Proglycem Oral Suspension - Apixaban Tablets 2.5 mg and 5 mg
Approved: December 23, 2019 - Mylan Pharmaceuticals Inc.; Micro Labs Limited
Generic for: Eliquis - Ziprasidone Mesylate Injection 20 mg (base) /mL
Approved: December 26, 2019 - Gland Pharma Limited
Generic for: Geodon Injection - Mirabegron Extended Release Tablets 25 mg
Approved: December 27, 2019 - Sawai USA Inc.
Generic for: Myrbetriq