First-Time Generic Drug Approvals 2020*

Generic Name

Manufacturer

Brand (Trade) Name

Esomeprazole Magnesium Delayed-Release for Oral Suspension, 10 mg 

Cipla Limited 

Nexium (Esomeprazole Magnesium) Delayed-Release for Oral Suspension, 10 mg

3/23/2020 

For the treatment of gastroesophageal reflux disease, risk reduction of NSAID associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence, and pathological hypersecretory conditions

Esomeprazole Magnesium Delayed-Release for Oral Suspension, 20 mg, 40 mg 

Cipla Limited 

Nexium (Esomeprazole Magnesium) Delayed-Release for Oral Suspension, 20 mg, 40 mg  

3/23/2020 

For the treatment of gastroesophageal reflux disease, risk reduction of NSAID associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence, and pathological hypersecretory conditions

Carfilzomib for Injection, 30 mg Single-Dose Vial 

Apotex Inc.

Kyprolis (Carfilzomib) for Injection, 30 mg Single-Dose Vial  

3/20/2020 

For the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy

Dabigatran Etexilate Capsules, 75 mg, 150 mg

Alkem Laboratories Limited.

Pradaxa (Dabigatran Etexilate) 75 mg, 150 mg

3/11/2020 

To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE); for the prophylaxis of DVT and PE in certain patients

Prednisolone Sodium Phosphate Oral Solution, 30 mg/5 mL  

Pharmaceutical Associates, Inc. 

Orapred (Prednisolone Sodium Phosphate) Oral Solution, 30 mg/5 ml

3/11/2020 

For the control of severe or incapacitating allergic conditions: seasonal or perennial allergic rhinitis; asthma, contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions

Melphalan for Injection, 50 mg Single-Dose Vial 
 

Actavis LLC 

Evomela (Melphalan) for Injection, 50 mg Single-Dose Vial  

3/6/2020

For the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate

Thiotepa for Injection USP, 15 mg/vial, 100 mg/vial Single-Dose Vials

MSN Laboratories Private Limited 

Tepadina (Thiotepa) for Injection USP, 15 mg/vial, 100 mg/vial Single-Dose Vials

3/4/2020 

For the treatment of adenocarcinoma of the breast or ovary; controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities; treating superficial papillary carcinoma of the urinary bladder

Metformin Hydrochloride Oral Solution, 500 mg/5 mL  

Saptalis Pharmaceuticals LLC

Riomet (Metformin Hydrochloride) Oral Solution,
500 mg/5 mL

3/3/2020 

For improving glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus

Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) 

Custopharm, Inc.

Migranal (Dihydroergotamine Mesylate) Nasal Spray, 4 mg/mL

2/28/2020 

For the acute treatment of migraine headaches with or without aura

Pyrimethamine Tablets, 25 mg  

Cerovene, Inc.

Daraprim (Pyrimethamine) Tablets, 25 mg 

2/26/2020 

For the treatment of toxoplasmosis when used conjointly with a sulfonamide

Albuterol Sulfate Inhalation Aerosol, 90 mcg/actuation

Perrigo Pharmaceuticals Company

ProAir HFA (Albuterol Sulfate Inhalation Aerosol), 90 mcg/actuation

2/24/2020

For the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease; prevention of exercise-induced bronchospasm in patients 4 years of age and older

Olopatadine Hydrochloride Ophthalmic
Solution USP, 0.7%

Watson Laboratories, Inc.

Pazeo (Olopatadine Hydrochloride) Ophthalmic Solution. 0.7%

2/19/2020 

For the treatment of ocular itching associated with allergic conjunctivitis

Naproxen and Esomeprazole Magnesium Delayed-Release Tablets, 375 mg/20 mg and 500 mg/20 mg 

Dr. Reddy's Laboratories Limited

Vimovo (Naproxen and Esomeprazole Magnesium)Delayed-Release Tablets,375 mg/20 mg and 500 mg/20 mg

2/18/2020 

For the symptomatic relief of arthritis to decrease the risk of developing naproxen-associated gastric ulcers.

Sodium Iodide I 131 Solution USP and Sodium Iodide I 131 Capsules USP,1000 mCi/mL

International Isotopes, Inc.

Hicon (Sodium Iodide I 131) Solution and Capsules, 1000 mCi/mL,

2/5/2020 

For the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid

Hydrocodone Bitartrate Extended-Release Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg

Alvogen Malta Operations Ltd.

Zohydro ER (Hydrocodone Bitartrate Extended-Release) Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg

1/21/2020

For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequat