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 2017*

 ANDA NumberGeneric NameANDA ApplicantBrand NameANDA Approval DateANDA Indication+
7207952Logilia Ulipristal Acetate, 30 mgTeva Pharmaceuticals USA, Inc. Ella (Ulipristal Acetate) Tablets, 30 mg 2/13/2017For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure
6206939Cefixime for Oral Suspension USP, 500 mg/5 mLBelcher Pharmaceuticals, LLCSuprax (Cefixime) for Oral Suspension, 500 mg/5 mL 2/6/2017To reduce the development of drug-resistant bacteria and maintain the effectiveness for oral suspension
 5208328Memantine and Donepezil Hydrochlorides Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mgAmneal Pharmaceuticals LLCNamzaric (Memantine and Donepezil Hydrochlorides) Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg 1/27/2017For the treatment of moderate to severe dementia of the Alzheimer’s type
4206836Dalfampridine Extended-Release Tablets, 10 mgActavis Laboratories FL, Inc.Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg 1/23/2017To improve walking in patients with multiple sclerosis (MS)
3206811Dalfampridine Extended-Release Tablets, 10 mgAurobindo Pharma LimitedAmpyra (Dalfampridine) Extended-Release Tablets, 10 mg 1/23/2017To improve walking in patients with multiple sclerosis (MS)
2 202090Sodium Oxybate Oral Solution, 500 mg/mLRoxane Laboratories, Inc.Xyrem (Sodium Oxybate) Oral Solution, 500 mg/mL 1/17/2017For the treatment of Cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy
1 207160Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mLAurobindo Pharma LimitedLevetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL 1/4/2017Antiepileptic drug indicated for adjunct therapy in adults (≥16 years of age) with certain seizure types when oral administration is temporarily not feasible

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.

Page Last Updated: 02/21/2017
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