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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 2026*

 ANDA NumberGeneric NameANDA ApplicantBrand NameANDA Approval DateANDA Indication+
19220483Norepinephrine Bitartrate in 5% Dextrose Injection Sagent PharmaceuticalsNorepinephrine Bitartrate in 5% Dextrose Injection 3/26/2026For restoration of blood pressure in adult patients with acute hypotensive states. 
18208959Rifaximin Tablet Actavis Laboratories FL, Inc.Xifaxan Tablet 3/19/2026For treatment of travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older. 
17219985Citalopram Hydrobromide Capsule Aurobindo Pharma LimitedCitalopram Hydrobromide Capsule 3/13/2026For treatment of Major Depressive Disorder (MDD) in adults.
16212563Ferric Citrate Tablet Teva Pharmaceuticals USA, Inc.Auryxia Tablet 3/11/2026For the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis.
15219997Mesalamine ER Capsule DifGen Pharmaceuticals LLCPentasa ER Capsule 3/10/2026For the induction of remission and for the treatment of mildly to moderately active ulcerative colitis in adult patients.
14218851Aprepitant Injection Mylan Pharmaceuticals Inc.Aponvie Injection 3/5/2026For the prevention of postoperative nausea and vomiting (PONV) in adults. 
13219602Fluticasone Propionate Aerosol Glenmark Specialty SAFlovent HFA Aerosol 3/3/2026For maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.
12218249Brivaracetam Injection Hainan Poly Pharm. Co., LTD.Briviact Injection 2/23/2026For the treatment of partial-onset seizures in patients 1 month of age and older.
11217953Ipratropium Bromide Aerosol Armstrong Pharmaceuticals, Inc.Atrovent HFA Aerosol 2/23/2026For maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 
10214924Brivaracetam Injection MSN Laboratories Private LimitedBriviact Injection 2/23/2026For the treatment of partial-onset seizures in patients 1 month of age and older.
9214880Brivaracetam Injection Micro Labs LimitedBriviact Injection 2/23/2026For the treatment of partial-onset seizures in patients 1 month of age and older.
8214922Brivaracetam Solution MSN Laboratories Private LimitedBriviact Solution 2/19/2026For the treatment of partial-onset seizures in patients 1 month of age and older.
7216921Idelalisib Tablet Natco Pharma LimitedZydelig Tablet 2/17/2026For the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
6214095Emtricitabine, Rilpivirine and Tenofovir Alafenamide Tablet Apotex Inc.Odefsey Tablet 1/30/2026For the treatment of HIV-1 infection in adult and pediatric patients weighing at least 25kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL; or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.
5218798Rilpivirine Tablet Somerset Therapeutics, LLCEdurant Tablet 1/29/2026For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 2 years of age and older and weighing at least 14 kg with plasma HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy in combination with other antiretroviral agents.
4214378Tapentadol Hydrochloride Tablet Humanwell Pharmaceutical US, Inc.Nucynta Tablet 1/27/2026For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40 kg.
3219119Tapentadol Hydrochloride Solution Novitium Pharma LLCNucynta Solution 1/26/2026For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adults and pediatric patients aged 6 years and older with a body weight of at least 16 kg.
2219323Mirabegron ER, For Suspension Alkem Laboratories LimitedMyrbetriq Granules, For Suspension 1/20/2026For the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency, either alone or in combination with the muscarinic antagonist solifenacin succinate.
1219167Bortezomib Powder, For Injection Gland Pharma LimitedBortezomib Powder, For Injection 1/6/2026For treatment of adult patients with multiple myeloma and mantle cell lymphoma.

 

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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