Drugs

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 NumberGeneric NameANDA ApplicantBrand NameANDA Approval DateANDA Indication+
16211694 Pyridostigmine Bromide Syrup, 60 mg/5 mL Novitium Pharma LLCMestinon (Pyridostigmine Bromide) Syrup, 60 mg/5 mL3/8/2019 To improve muscle strength in patients with myasthenia gravis 
15205600Levofloxacin Ophthalmic Solution, 1.5%Micro Labs Limited, India  Iquix (Levofloxacin) Opthalmic Solution, 1.5%2/27/2019For the treatment of corneal ulcer caused by susceptible strains of the following bacteria
 
14208800Deferiprone Tablets, 500 mgTaro Pharmaceuticals Industries Limited Ferriprox (Deferiprone) Tablets, 500 mg2/8/2019For the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate
13204724Sevelamer Hydrochloride Tablets, 400 mg, 800 mgGlenmark Pharmaceuticals Limited        Renagel (Sevelamer Hydrochloride) Tablets, 400 mg, 800 mg2/8/2019For the control of serum phosphorus in patients with chronic kidney disease on dialysis
12210790 Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, 120 mgAmneal Pharmaceuticals Company GmbHFetzima (Levomilnacipran) Extended-Release Capsules, 20 mg, 40 mg, 80 mg, 120 mg2/4/2019For the treatment of Major Depressive Disorder
11208702 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
 
10208891Wixela 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 mcg1/30/2019

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)

9211040Sirolimus Oral Solution, 1 mg/mLNovitium Pharma LLCRapamune (Sirolimus) Oral Solution, 1 mg/mL1/28/2019

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

8209822Vigabatrin Tablets USP, 500 mgTeva Pharmaceuticals USA, Inc.Sabril (Vigabatrin) Tablets, 500 mg1/14/2019For the treatment of refractory complex partial seizures (CPS) in patients 10 years of age and older who have responded inadequately to several alternative treatments
7209019Ingenol Mebutate Gel, 0.05%Perrigo UK FINCO Limited PartnershipPicato Gel (Ingenol Mebutate) Gel, 0.05%1/9/2019For the topical treatment of actinic keratosis
6209018Ingenol Mebutate Gel, 0.015%Perrigo UK FINCO Limited PartnershipPicato Gel (Ingenol Mebutate) Gel, 0.015%1/7/2019For the topical treatment of actinic keratosis
5208055Lurasidone 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  1/3/2019For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults
4208049Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mgAccord Healthcare Inc. Latuda (Lurasidone Hydrochloride) Tablets, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg 1/3/2019For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults
3208031Lurasidone 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 mg1/3/2019 For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults
2208028Lurasidone 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 mg1/3/2019 For the treatment of schizophrenia and depressive episodes associated with Bipolar I Disorder (bipolar depression) in adults
1208002Lurasidone 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 mg1/3/2019 
 
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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Page Last Updated: 03/08/2019
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