First-Time Generic Drug Approvals for 2016
January
- Naftifine Hydrochloride Cream 2%
Approved: January 6, 2016 - Taro Pharmaceuticals U.S.A., Inc.
Generic for: Naftin Cream - Deferasirox Tablets For Oral Suspension 125 mg, 250 mg and 500 mg
Approved: January 26, 2016 - Actavis Elizabeth, LLC
Generic for: Exjade - Milnacipran Hydrochloride Tablets 12.5 mg, 25 mg, 50 mg and 100 mg
Approved: January 27, 2016 - Liberty Pharma, Inc.
Generic for: Savella
February
- Efavirenz Tablets 600 mg
Approved: February 17, 2016 - Mylan Pharmaceuticals Inc.
Generic for: Sustiva - Carbidopa Tablets 25 mg
Approved: February 17, 2016 - Edenbridge Pharmaceuticals LLC
Generic for: Lodosyn - Sumatriptan Nasal Spray USP, 5 mg/spray and 20 mg/spray
Approved: February 19, 2016 - Lannett Holdings, Inc.
Generic for: Imitrex Nasal Spray - Diclofenac Potassium Capsules 25 mg
Approved: February 23, 2016 - Bionpharma Inc.
Generic for: Zipsor - Sodium Phenylacetate and Sodium Benzoate Injection 10%/10%
Approved: February 24, 2016 - Ailex Pharmaceutical Pvt Ltd.
Generic for: Ammonul - Fluticasone Propionate Nasal Spray USP, 50 mcg/spray
Approved: February 29, 2016 - Apotex Corp.
Generic for: Flonase Allergy Relief
March
- Oxiconazole Nitrate Cream 1%
Approved: March 7, 2016 - Taro Pharmaceuticals USA, Inc.
Generic for: Oxistat Cream - Sildenafil Citrate Tablets 25 mg (base), 50 mg (base), 100 mg (base)
Approved: March 9, 2016 - Teva Pharmaceuticals USA, Inc.
Generic for: Viagra - Diclofenac Sodium Topical Gel 1%
Approved: March 18, 2016 - Amneal Pharmaceuticals LLC
Generic for: Voltaren Gel - Mometasone Furoate Nasal Spray 0.05 mg base/spray
Approved: March 22, 2016 - Apotex, Inc.
Generic for: Nasonex - Bendamustine Hydrochloride for Injection 25 mg/vial and 100 mg/vial
Approved: March 24, 2016 - Glenmark Pharmaceuticals Inc., USA; Innopharma, Inc.
Generic for: Treanda - Daptomycin for Injection 500 mg/vial
Approved: March 24, 2016 - Teva Pharmaceuticals USA, Inc.
Generic for: Cubicin - Ibuprofen Lysine Injection 20 mg (base)/2 mL
Approved: March 30, 2016 - Exela Pharma Sciences
Generic for: NeoProfen
April
- Rosiglitazone Maleate and Glimeperide Tablets 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg, 8 mg/2 mg and 8 mg/8 mg
Approved: April 1, 2016 - Teva Pharmaceuticals USA, Inc.
Generic for: Avandaryl - Flurandrenolide Cream USP, 0.05%
Approved: April 13, 2016 - Teligent Pharma, Inc.
Generic for: Cordran SP Cream - Fosamprenavir Calcium Tablets 700 mg
Approved: April 15, 2016 - Mylan Pharmaceuticals, Inc.
Generic for: Lexiva Tablets - Lacosamide Oral Solution 10 mg/mL
Approved: April 28, 2016 - Amneal Pharmaceuticals
Generic for: Vimpat Oral Solution - Lacosamide Tablets 50 mg, 100 mg, 150 mg and 200 mg
Approved: April 28, 2016 - Actavis Pharma, Inc.; MSN Laboratories; Alembic Pharmaceuticals Limited; Aurobindo Pharma Limited; Mylan Pharmaceuticals Inc.; Sun Pharmaceutical Industries, Inc.
Generic for: Vimpat - Rosuvastatin Calcium Tablets 5 mg, 10 mg, 20 mg and 40 mg
Approved: April 29, 2016 - Watson Pharmaceuticals Inc.
Generic for: Crestor
May
- Diclofenac Potassium for Oral Solution 50 mg
Approved: May 2, 2016 - Par Formulations Private Limited
Generic for: Cambia For Oral Solution - Estradiol Valerate and Estradiol Valerate/Dienogest Tablets 3 mg, 2 mg/2 mg, 2 mg/3 mg and 1 mg
Approved: May 6, 2016 - Watson Laboratories, Inc.
Generic for: Natazia - Rufinamide Tablets 200 mg and 400 mg
Approved: May 16, 2016 - Roxane Laboratories, Inc.; Glenmark Pharmaceuticals Inc., USA; Mylan Pharmaceuticals Inc.
Generic for: Banzel - Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg
Approved: May 23, 2016 - Mylan Pharmaceuticals, Inc.
Generic for: Doxteric - Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate Tablets 1 mg/0.02 mg and 75 mg
Approved: May 24, 2016 - Lupin Pharmaceuticals, Inc.
Generic for: Minastrin 24 Fe - Febuxostat Tablets 40 mg and 80 mg
Approved: May 24, 2016 - Sun Pharma Global FZE
Generic for: Uloric
June
- Dofetilide Capsules 125 mcg, 250 mcg and 500 mcg
Approved: June 6, 2016 - Mayne Pharma
Generic for: Tikosyn - Fosaprepitant Dimeglumine Injection 150mg (base)/vial
Approved: June 9, 2016 - Fresenius Kabi USA
Generic for: Emend for Injection - Dasatinib Tablets 20mg, 50mg, 70mg and 100mg
Approved: June 10, 2016 - Apotex, Inc.
Generic for: Sprycel - Levoleucovorin for Injection 50 mg/vial
Approved: June 16, 2016 - Eurohealth International Sarl
Generic for: Fusilev - Fenofibrate Tablets USP, 40 mg and 120 mg
Approved: June 23, 2016 - Mylan Pharmaceuticals Inc.
Generic for: Fenoglide - Ethacrynic Acid Tablets USP, 25 mg
Approved: June 30, 2016 - Edenbridge Pharmaceuticals, LLC
Generic for: Edecrin
July
- Omeprazole and Sodium Bicarbonate Capsules 20 mg/1100 mg
Approved: July 15, 2016 - Perrigo Company; Par Pharmaceutical Inc.; Actavis Pharma, Inc.
Generic for: Zegerid OTC - Nilutamide Tablets 150 mg
Approved: July 15, 2016 - ANI Pharmaceuticals, Inc.
Generic for: Nilandron - Valganciclovir for Oral Solution 50 mg/mL
Approved: July 18, 2016 - Actavis Pharma, Inc.
Generic for: Valcyte for Oral Solution
August
- Zolpidem Tartrate Sublingual Tablets 5 mg and 10 mg
Approved: August 1, 2016 - Par Pharmaceutical, Inc.
Generic for: Edluar - Oseltamivir Phosphate Capsules 30 mg, 45 mg, 75 mg
Approved: August 3, 2016 - Natco Pharma Limited
Generic for: Tamiflu - Doxylamine Succinate and Pyridoxine Hydrochloride Delayed Release Tablets 10 mg/10 mg
Approved: August 19, 2016 - Actavis Pharma, Inc.
Generic for: Diclegis
September
- Abacavir Oral Solution 20 mg/mL
Approved: September 26, 2016 - Hetero Labs Limited Unit III
Generic for: Ziagen Oral Solution - Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg
Approved: September 26, 2016 - Lupin Limited; Mylan Pharmaceuticals, Inc.; Sun Pharma Global FZE
Generic for: Namenda XR
October
- Ribavirin for Inhalation Solution USP, 6 g/vial
Approved: October 6, 2016 - Navinta LLC
Generic for: Virazole - Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets 3 mg/ 0.03 mg/ 0.451 mg and 0.451 mg
Approved: October 11, 2016 - Watson Laboratories, Inc.
Generic for: Safyral - Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and and Levomefolate Calcium Tablets 3 mg/ 0.02mg/ 0.451 mg and 0.451 mg
Approved: October 11, 2016 - Watson Laboratories, Inc.
Generic for: Beyaz - Olmesartan Medoxomil Tablets 5 mg, 20 mg and 40 mg
Approved: October 26, 2016 - Mylan Pharmaceuticals Inc.
Generic for: Benicar - Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20 mg/ 12.5 mg, 40 mg/ 12.5 mg, and 40 mg/ 25 mg
Approved: October 26, 2016 - Mylan Pharmaceuticals Inc.
Generic for: Benicar HCT - Amlodipine and Olmesartan Medoxomil Tablets 5 mg/ 20 mg, 5 mg/ 40 mg, 10 mg/ 20 mg, and 10 mg/ 40 mg
Approved: October 26, 2016 - Macleods Pharmaceuticals Limited; Teva Pharmaceuticals USA, Inc.
Generic for: Azor - Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets 20 mg/ 5 mg/ 12.5 mg, 40 mg/ 5 mg/ 12.5 mg, 40 mg/ 5 mg/ 25 mg, 40 mg/ 10 mg/ 12.5 mg, and 40 mg/ 10 mg/ 25 mg
Approved: October 26, 2016 - Par Pharmaceutical, Inc.; Torrent Pharmaceuticals Limited
Generic for: Tribenzor
November
- Quetiapine Fumarate Extended-Release Tablets 400 mg
Approved: November 1, 2016 - Accord Healthcare Inc.
Generic for: Seroquel XR 400 mg - Iloperidone Tablets 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg
Approved: November 28, 2016 - Inventia Healthcare Private Limited
Generic for: Fanapt - Dexmethylphenidate Hydrochloride Extended-Release Capsules 25 mg and 35 mg
Approved: November 30, 2016 - Par Pharmaceutical, Inc.
Generic for: Focalin XR
December
- Pitavastatin Calcium Tablets 1 mg (base), 2 mg (base), and 4 mg (base)
Approved: December 20, 2016 - Aurobindo Pharma Ltd.
Generic for: Livalo - Lopinavir and Ritonavir Oral Solution 80 mg / 20 mg per mL
Approved: December 27, 2016 - Silarx Pharmaceuticals Inc.
Generic for: Kaletra Oral Solution