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+ | |
|---|---|---|---|---|---|---|
| 50 | 208786 | Diclofenac Sodium Injection, 37.5 mg/mL Single-Dose Vials | Mylan Laboratories Limited | Dyloject (Diclofenac Sodium) Injection, 37.5 mg/mL Single-Dose Vials | 6/18/2019 | For the management of mild to moderate pain; management of moderate to severe pain alone or in combination with opioid analgesics |
| 49 | 212260 | Sildenafil for Oral Suspension, 10 mg/mL | Novitium Pharma LLC | Revatio (Sildenafil) for Oral Suspension, 10 mg/mL | 5/31/2019 | For the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening |
| 48 | 204902 | Dapiprazole Hydrochloride Ophthalmic Solution, 0.5% | Baradaina, LLC. | Dapiprazole Hydrochloride Ophthalmic Solution, 0.5% | 5/29/2019 | For the treatment of iatrogenically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents |
| 47 | 207344 | Micafungin for Injection, 50 mg/vial and 100 mg/vial Single-Dose Vials | Fresenius Kabi USA, LLC. | Mycamine for Injection, 50 mg/vial and 100 mg/vial | 5/17/2019 | For the treatment candidemia, acute disseminated candidiasis, candida peritonitis and abscesses; also for the treatment esophageal Candidiasis and prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation |
| 46 | 207200 | Sapropterin Dihydrochloride Tablets, 100 mg | Par Pharmaceutical, Inc | Kuvan (Sapropterin Dihydrochloride) Tablets, 100 mg | 5/10/2019 | For the reduction of blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU) |
| 45 | 207873 | Mesalamine Delayed-Release Capsules, 400 mg | Teva Pharmaceuticals USA, Inc. | Delzicol (Mesalamine) Delayed-Release Capsules, 400 mg | 5/9/2019 | For the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older; Maintenance of remission of ulcerative colitis in adults |
| 44 | 209921 | Penicillamine Capsules USP, 250 mg | Amerigen Pharmaceuticals, Ltd. | Cuprimine (Penicillamine) Capsules, 250 mg | 5/7/2019 | For the treatment of Wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy |
| 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.