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 Number||Generic Name||ANDA Applicant||Brand Name||ANDA Approval Date||ANDA Indication+|
|7||207952||Logilia Ulipristal Acetate, 30 mg||Teva Pharmaceuticals USA, Inc.||Ella (Ulipristal Acetate) Tablets, 30 mg||2/13/2017||For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure|
|6||206939||Cefixime for Oral Suspension USP, 500 mg/5 mL||Belcher Pharmaceuticals, LLC||Suprax (Cefixime) for Oral Suspension, 500 mg/5 mL||2/6/2017||To reduce the development of drug-resistant bacteria and maintain the effectiveness for oral suspension|
|5||208328||Memantine and Donepezil Hydrochlorides Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg||Amneal Pharmaceuticals LLC||Namzaric (Memantine and Donepezil Hydrochlorides) Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg||1/27/2017||For the treatment of moderate to severe dementia of the Alzheimer’s type|
|4||206836||Dalfampridine Extended-Release Tablets, 10 mg||Actavis Laboratories FL, Inc.||Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg||1/23/2017||To improve walking in patients with multiple sclerosis (MS)|
|3||206811||Dalfampridine Extended-Release Tablets, 10 mg||Aurobindo Pharma Limited||Ampyra (Dalfampridine) Extended-Release Tablets, 10 mg||1/23/2017||To improve walking in patients with multiple sclerosis (MS)|
|2||202090||Sodium Oxybate Oral Solution, 500 mg/mL||Roxane Laboratories, Inc.||Xyrem (Sodium Oxybate) Oral Solution, 500 mg/mL||1/17/2017||For the treatment of Cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy|
|1||207160||Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL||Aurobindo Pharma Limited||Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL||1/4/2017||Antiepileptic 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.