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  1. How Drugs are Developed and Approved

First Generic Drug Approvals

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 2019*

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+
43 209742   Bosentan Tablets, 62.5 mg, 125 mg        Amneal Pharmaceuticals Company GmbH     Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg      4/26/2019   For the treatment for pulmonary arterial hypertension
42 209324   Bosentan Tablets, 62.5 mg, 125 mg       Sun Pharmaceutical Industries Limited   Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg     4/26/2019     For the treatment for pulmonary arterial hypertension
41 208695   Bosentan Tablets, 62.5 mg, 125 mg       West-Ward Pharmaceuticals International Limited   Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg       4/26/2019   For the treatment for pulmonary arterial hypertension
40 207110     Bosentan Tablets, 62.5 mg, 125 mg         Watson Laboratories, Inc.      Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg     4/26/2019     For the treatment for pulmonary arterial hypertension
39 206987     Bosentan Tablets, 62.5 mg, 125 mg      Natco Pharma Limited   Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg       For the treatment for pulmonary arterial hypertension
38 207760 Bosentan Tablets, 62.5 mg, 125 mg        Zydus Pharmaceuticals (USA) Inc. Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg 4/26/2019 For the treatment for pulmonary arterial hypertension
37 206002     Bosentan Tablets, 62.5 mg, 125 mg      Alvogen Pine Brook LLC     Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg        4/26/2019     For the treatment for pulmonary arterial hypertension
36 205699   Bosentan Tablets, 62.5 mg, 125 mg     Par Pharmaceutical, Inc.     Tracleer (Bosentan) Tablets, 62.5 mg, 125 mg         4/26/2019   For the treatment for pulmonary arterial hypertension
35 206667 Pentamidine Isethionate for Inhalation Solution, 300 mg/vial     Seton Pharmaceuticals, LLC     NebuPent (Pentamidine Isethionate) Powder for inhalation Solution, 300 mg/vial         4/24/2019     For the prevention of Pneumocystis jiroveci pneumonia (PJP) in high risk, HIV-infected patients defined by one or both of the following crtieria: (i) a history of one or more episodes of PJP; (ii) a peripheral CD4+ lymphocyte count less than 200/mm
34 211388  Rufinamide Oral Suspension, 40 mg/mL        Bionpharma Inc.   Banzel (Rufinamide) Oral Suspension, 40 mg/mL      4/23/2019     For the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS)
33 207363 Rufinamide Oral Suspension, 40 mg/mL     Hikma Pharmaceuticals International Limited     Banzel (Rufinamide) Oral Suspension, 40 mg/mL        4/23/2019 For the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS)
32 210130     Everolimus Tablets for Oral Suspension, 2 mg, 3 mg, 5 mg          Mylan Pharmaceuticals, Inc.      Afinitor Disperz (Everolimus) Tablets for Oral Suspension, 2 mg, 3 mg, 5 mg        4/19/2019 For the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected
31 209522     Naloxone Hydrochloride Nasal Spray, 4 mg/spray      Teva Pharmaceuticals USA, Inc.     Narcan (Naloxone Hydrochloride) Nasal Spray, 4 mg/spray     4/19/2019     For the emergency treatment of known or suspected opioid overdose
30 209371     Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 125 mg/31.25 mg per 5 mL, 250 mg/62.5 mg per 5 mL  Aurobindo Pharma Limited     Augmentin (Amoxicillin and Clavulanate Potassium) for Oral Suspension USP, 125 mg/31.25 mg per 5 mL, 250 mg/62.5 mg per 5 mL       4/19/2019   For treatment of lower respiratory tract infections, acute bacterial otitis media, sinusitis, skin and skin structure infections, and urinary tract infections
29 206430     Valrubicin Intravesical Solution USP, 200 mg/5 mL(40 mg/mL) in Single Dose Vials       Custopharm, Inc.     Valstar (Valrubicin) Intravesical Solution USP, 200 mg/5 mL (40 mg/mL) in Single Dose Vials  4/19/2019     For the intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality
28 207609   Loteprednol Etabonate Ophthalmic Suspension, 0.5%        Hi-tech Pharmacal Co., Inc.      Lotemax (Loteprednol Etabonate) Ophthalmic Suspension, 0.5%   4/17/2019     For the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis
27 091178     Mifepristone Tablets, 200 mg       GenBioPro, Inc.   Mifeprex (Mifepristone) Tablets, 200 mg          
26 208201     Naftifine Hydrochloride Gel USP, 2%         Taro Pharmaceuticals U.S.A. Inc.     Naftin (Naftifine Hydrochloride) Gel, 2%        4/10/2019     For the treatment of interdigital tinea pedis
25 208441

Ambrisentan Tablets, 5 mg, 10 mg

Mylan Pharmaceuticals Inc. Letairis (Ambrisentan) Tablets, 5 mg, 10 mg 3/28/2019 For the treatment of pulmonary arterial hypertension
24 208252 Ambrisentan Tablets, 5 mg, 10 mg Watson Laboratories, Inc Letairis (Ambrisentan) Tablets, 5 mg, 10 mg 3/28/2019 For the treatment of pulmonary arterial hypertension
23 210784

Ambrisentan Tablets, 5 mg, 10 mg

Sun Pharma Global FZE Letairis (Ambrisentan) Tablets, 5 mg, 10 mg 3/28/2019 For the treatment of pulmonary arterial hypertension
22 210058

Ambrisentan Tablets, 5 mg, 10 mg

Zydus Pharmaceuticals (USA) Inc. Letairis (Ambrisentan) Tablets, 5 mg, 10 mg 3/28/2019 For the treatment of pulmonary arterial hypertension
21 206665 Aliskiren Tablets, 150 mg, 300 mg  Anchen Pharmaceuticals, Inc. Tekturna (Aliskiren) Tablets, 150 mg, 300 mg  3/22/2019 For the treatment of hypertension in adults
 
20 206165 Naftifine Hydrochloride Gel, 1% Tolmar, Inc. Naftin (Naftifine Hydrochloride) Gel, 1% 3/20/2019 For the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans and Epidermophyton floccosum 
19 211694  Pyridostigmine Bromide Syrup, 60 mg/5 mL  Novitium Pharma LLC Mestinon (Pyridostigmine Bromide) Syrup, 60 mg/5 mL 3/8/2019  To improve muscle strength in patients with myasthenia gravis 
18 206066 Bepotastine Besilate Ophthalmic Solution, 1.5% Apotex Inc. Bepreve (Bepotastine Besilate) Ophthalmic Solution, 1.5% 3/8/2019 For the treatment of itching associated with signs and symptoms of allergic conjunctivitis 
17 209202 Esomeprazole Magnesium Delayed-Release Tablets, 20 mg (base) (OTC) Actavis Elizabeth LLC Nexium 24HR (Esomeprazole Magnesium) Delayed-Release Tablets, 20 mg (base) (OTC) 3/6/2019 For the treatment of frequent heartburn
 
16 210044 Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) Amneal Pharmaceuticals Company GmbH Faslodex (Fulvestrant) Injection, 250 mg/5 mL (50 mg/mL) 3/4/2019 For the treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy; for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy
 
15 205600 Levofloxacin Ophthalmic Solution, 1.5% Micro Labs Limited, India   Iquix (Levofloxacin) Opthalmic Solution, 1.5% 2/27/2019 For the treatment of corneal ulcer caused by susceptible strains of the following bacteria
 
14 208800 Deferiprone Tablets, 500 mg Taro Pharmaceuticals Industries Limited  Ferriprox (Deferiprone) Tablets, 500 mg 2/8/2019 For the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate
13 204724 Sevelamer Hydrochloride Tablets, 400 mg, 800 mg Glenmark Pharmaceuticals Limited         Renagel (Sevelamer Hydrochloride) Tablets, 400 mg, 800 mg 2/8/2019 For the control of serum phosphorus in patients with chronic kidney disease on dialysis
12 210790  Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, 120 mg Amneal Pharmaceuticals Company GmbH Fetzima (Levomilnacipran) Extended-Release Capsules, 20 mg, 40 mg, 80 mg, 120 mg 2/4/2019 For the treatment of Major Depressive Disorder
11 208702  Acyclovir Cream, 5%  Perrigo UK FINCO Limited Partnership   Zovirax (Acyclovir) Cream, 5% 2/4/2019  For the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older
 
10 208891 Wixela Inhub (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100 mcg/50 mcg, 250 mcg/50 mcg, 500 mcg/50 mcg  Mylan Pharmaceuticals Inc.  Advair Diskus (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100 mcg/50 mcg, 250 mcg/50 mcg, 500 mcg/50 mcg 1/30/2019

For the treatment of asthma in patients aged 4 years and older; and for the 250/50 strength, for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)

9 211040 Sirolimus Oral Solution, 1 mg/mL Novitium Pharma LLC Rapamune (Sirolimus) Oral Solution, 1 mg/mL 1/28/2019

For the prophylaxis of organ rejection in patients aged 13 years of age or older receiving renal transplants

8 209822 Vigabatrin Tablets USP, 500 mg Teva Pharmaceuticals USA, Inc. Sabril (Vigabatrin) Tablets, 500 mg 1/14/2019 For the treatment of refractory complex partial seizures (CPS) in patients 10 years of age and older who have responded inadequately to several alternative treatments
7 209019 Ingenol Mebutate Gel, 0.05% Perrigo UK FINCO Limited Partnership Picato Gel (Ingenol Mebutate) Gel, 0.05% 1/9/2019 For the topical treatment of actinic keratosis
6 209018 Ingenol Mebutate Gel, 0.015% Perrigo UK FINCO Limited Partnership Picato Gel (Ingenol Mebutate) Gel, 0.015% 1/7/2019 For the topical treatment of actinic keratosis
5 208055 Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 80 mg, 120 mg  Torrent Pharmaceuticals Limited  Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 80 mg, 120 mg   1/3/2019 For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults
4 208049 Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg Accord Healthcare Inc.  Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg  1/3/2019 For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults
3 208031 Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg    Lupin Limited  Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg 1/3/2019  For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults
2 208028 Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg  InvaGen Pharmaceuticals, Inc.  Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg 1/3/2019  For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults
1 208002 Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg   Amneal Pharmaceuticals Company GmbH  Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg 1/3/2019 
 
For the treatment of depressive episode associated with Bipolar I Disorder (bipolar depression) in adults

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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