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  1. Drug and Biologic Approval and IND Activity Reports

First Generic Drug Approvals

Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.

“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.

Note: Approved drugs are not always available on or after the listed approval date. Please contact the listed ANDA applicant for more information about a drug product’s availability.

First-Time Generic Drug Approvals 2020*

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+
42 211194 Dextrose 5% and Sodium Chloride Injection 0.3% USP, 250 mL, 500 mL, and 1,000 mL Bags Fresenius Kabi USA, LLC Dextrose 5% and Sodium Chloride Injection 0.3% USP, 250 mL, 500 mL, and 1,000 mL Bags 8/26/2020 For the parental replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient
41 210531 Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg Mylan Pharmaceuticals Inc. Tecfidera (Dimethyl Fumarate) Delayed-Release Capsules, 120 mg and 240 mg 8/17/2020 For the treatment of patients with relapsing forms of multiple sclerosis
40 205548 Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP Dr. Reddy's Laboratories Limited Ciprodex (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Otic Suspension 8/10/2020 For the treatment of infections caused by susceptible isolates of the designated microorganisms in: Acute Otitis Media (AOM) in pediatric patients with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa;
and in Acute Otitis Externa (AOE) in pediatric, adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa
39 211436 Mifepristone Tablets, 300 mg Teva Pharmaceuticals USA, Inc. Korlym (Mifepristone) Tablets, 300 mg 8/3/2020 For the control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery
38 213734 Metyrosine Capsules USP, 250 mg Amneal EU, Limited Demser (Metyrosine) Capsules, 250 mg 7/24/2020 For the treatment of pheochromocytoma for preoperative preparation of patients for surgery, management of patients when surgery is contraindicated, and chronic treatment of patients with malignant pheochromocytoma
37 213374 Deferasirox Oral Granules, 90 mg, 180 mg and 360 mg Alkem Laboratories Limited Jadenu Sprinkle (Deferasirox) Oral Granules, 90 mg, 180 mg and 360 mg 7/14/2020 For the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older
36 211421 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg Sunrise Pharmaceutical, Inc. Librax (Chlordiazepoxide Hydrochloride and Clidinium Bromide) Capsules, 5 mg/2.5 mg 7/7/2020 To control emotional and somatic factors in gastrointestinal disorders; as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome and acute enterocolitis
35 213725 Pantoprazole Sodium for Delayed-Release Oral Suspension, 40 mg Sun Pharmaceutical Industries Limited Protonix (Pantoprazole) Sodium for Delayed-Release Oral Suspension, 40 mg 6/30/2020 For the short-term treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD), for the maintenance of healing of erosive esophagitis, for pathologicall hypersecretory conditions Including Zollinger-Ellison (ZE) Syndrome
34 210924 Methylphenidate Extended-Release Orally Disintegrating Tablets, 8.6 mg, 17.3 mg, and 25.9 mg Actavis Elizabeth LLC Cotempla (Methylphenidate) XR-ODT Extended-Release Orally Disentegrating Tablets, 8.6 mg, 17.3 mg, 25.9 mg 6/19/2020 For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age
33 211722 Betamethasone Dipropionate Spray, 0.05% Taro Pharmaceuticals Inc. Sernivo (Betamethasone Dipropionate) Spray, 0.05% 6/17/2020 For the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older
32 211464 Halobetasol Propionate Lotion, 0.05% Perrigo Israel Pharmaceuticals Limited Ultravate (Halobetasol Propionate) Lotion, 0.05% 6/3/2020 For the topical treatment of plaque psoriasis in patients 18 years of age and older
31 209487 Meloxicam Capsules, 5 mg and 10 mg Lupin Limited Vivlodex (Meloxicam) Capsules, 5 mg, 10 mg 6/1/2020 For the management of osteoarthritis pain
30 211891  Tolvaptan Tablets, 15 mg, 30 mg, and 60 mg Alkem Laboratories Limited Samsca Tablets, 15 mg, 30 mg, and 60 mg 5/19/2020 For the treatment of clinically significant hypervolemic and euvolemic hyponatremia
29 207605  Tolvaptan Tablets, 15 mg and 30 mg Apotex Inc. Samsca Tablets, 15 mg and 30 mg 5/19/2020 For the treatment of clinically significant hypervolemic and euvolemic hyponatremia
28 208773  Posaconazole Oral Suspension, 200 mg/5 mL (40 mg/mL) Hikma Pharmaceuticals USA, Inc Noxafil (Posaconazole) Oral Suspension, 200 mg/5 mL (40 mg/mL) 5/15/2020 For the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised,  and for the treatment of oropharyngeal candidiasis
27 209457  Icosapent Ethyl Capsules, 1 gram Hikma Pharmaceuticals USA Inc Vascepa  (Icosapent Ethyl) Capsules, 1 gram 5/15/2020  Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia
26 213038  Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg Laurus Labs Limited SYMFI LO  (Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate) Tablets, 400 mg/300 mg/300 mg 5/14/2020  A complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg
25 212786  Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg Laurus Labs Limited SYMFI (Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate) Tablets, 600 mg/300 mg/300 mg 5/14/2020  A complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg
24 211571  Esomeprazole Magnesium Delayed-Release Tablets, 20 mg (base) (OTC) Dr. Reddy's Laboratories Limited Nexium 24HR Delayed-Release Tablets (Esomeprazole Magnesium) Delayed-Release Tablets, 20 mg (base) (OTC) 5/14/2020  For the treatment of frequent heartburn (occurs 2 or more days a week)
23 210765  Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% Tolmar, Inc. Taclonex Topical Suspension,  (Calcipotriene and Betamethasone) Topical Suspension, 0.005%/0.064% 5/11/2020  For the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older
22 202470  Desonide Gel, 0.05% Teresina Holdings LLC  Desonate  (Dseonide) Gel 0.05% 5/11/2020  For the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older
21 205789  Ursodiol Capsules USP, 200 mg, 400 mg. Nexgen Pharma, Inc.  Actigall ( Ursidiol) Capsules USP, 200 mg., 400 mg. 5/8/2020  For the treatment and prevention of gallstones
20 210720  Ivermectin Lotion, 0.5% Taro Pharmaceutical Industries Ltd. Sklice (Ivermectin) Lotion, 0.5% 5/6/2020  For the topical treatment of head lice infestations in patients 6 months of age and older
19 211880 Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL, Multiple-Dose Vials International Medication Systems, Limited Adrenalin (Epinephrine) Injection USP, 30 mg/30 mL (1 mg/mL), Multiple-Dose Vials 4/24/2020  For the emergency treatment of allergic reactions (Type 1), including anaphylaxis; to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock
18 206370 Clocortolone Pivalate Cream USP, 0.1% Taro Pharmaceuticals USA, Inc. Cloderm (Clocortolone Pivalate) Cream USP, 0.1% 4/21/2020  For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
17 211586 Buprenorphine Transdermal System, 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr, and 20 mcg/hr Amneal Pharmaceuticals LLC Butrans (Buprenorphine) Transdermal System, 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr, and 20 mcg/hr 4/14/2020  For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate
16 209959 Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation Cipla Limited  Proventil HFA (Albuterol Sulfate) Inhalation Aerosol, 90 mcg (base)/actuation 4/8/2020  For the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in adults and children 4 years of age and older
15 211752 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
14 211751  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
13 211185  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
12 208040
 
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

11 204962 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
10 209323 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
9 213049  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
8 211309 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
7 211393
 
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
6 207127 
 
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
5 203760 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
4 208637
 
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
3 204206 
 
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.
2 209166
 
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
1 206986 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 inadequate

Note: As outlined in the Proposed Criteria for First Generic Submissions for Purposes of ANDA, certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.

*This table reflects current data as of the date the listed approval was made. Post-approval status changes, including approved use or indications, approval date, approval status, etc. are not reflected here. To view the most current information on any ANDA listed, please check its Drugs@FDA listing.
+Due to space limitations, abbreviated indications are listed. For full indication information, please check Drugs@FDA.

To view all Generic Drug Approvals and Tentative Approvals, use the "Drug Approval Reports by Month" feature on Drugs@FDA and select "Original Abbreviated New Drug Approvals (ANDAs) by Month" for Generic Approvals or "Tentative Approvals by Month" for Tentative Approvals. The database is updated daily.



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