First-Time 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+
20	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
19	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
18	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
17	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
16	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
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.

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/default.htm