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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 2023*

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+
13 214226 Tenofovir Alafenamide Tablets, 25 mg Lupin Limited Vemlidy (Tenofovir Alafenamide) Tablets 3/30/203 For the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease
12 214688 Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064% Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam 3/21/2023 For the topical treatment of plaque psoriasis in patients 12 years and older
11 209738 Tofacitinib Tablets, 5 mg and 10 mg Micro Labs Limited Xeljanz (Tofacitinib) Tablets 3/13/2023 For the treatment of adult patients with moderately to severely active rheumatoid arthritis; active psoriatic arthritis; moderately to severely active ulcerative colitis
10 205770 Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules, 140 mg/125 mg/125 mg Par Pharmaceutical, Inc. Pylera (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride) Capsules 3/6/2023 For the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori
9 214836 Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) L. Perrigo Company Advil Dual Action with Acetaminophen (Acetaminophen and Ibuprofen) Tablets (OTC) 2/28/2023 Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis
8 217219 Tiopronin Delayed-Release Tablets, 100 mg and 300 mg Par Pharmaceutical, Inc. Thiola (Tiopronin) EC Tablets 2/24/2023 For the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone
7 215408 Doxepin Hydrochloride Cream, 5% Teva Pharmaceuticals Development, Inc. Zonalon (Doxepin Hydrochloride) Cream 2/17/2023 For the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus
6 216167 Topiramate Extended-Release Capsules, 200 mg Zydus Pharmaceuticals (USA) Inc. Trokendi XR (Topiramate) Extended-Release Capsules 2/9/2023 Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older; preventive treatment of migraine in patients 12 years of age and older
5 213947 Tirofiban Hydrochloride Injection, 5 mg/100 mL (50 mcg/mL), Single-Dose Containers Nexus Pharmaceuticals, Inc. Aggrastat (Tirofiban Hydrochloride) Injection 2/7/2023 To reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome
4 213073 Cysteine Hydrochloride Injection USP, 725 mg/10 mL (72.5 mg/mL) Nivagen Pharmaceuticals, Inc. Cysteine Hydrochloride Injection 1/26/2023 For use as an additive to amino acids solutions to meet nutritional requirements of newborn infants requiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN
3 211452 Morphine Sulfate Injection USP, 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, 15 mg/mL Hikma Pharmaceuticals International Limited Morphine Sulfate Injection 1/12/2023 For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
2 216496 Phenylephrine Hydrochloride Ophthalmic Solution USP, 10 % Mankind Pharma Limited Phenylephrine Hydrochloride Ophthalmic Solution 1/11/2023 For the purpose of dilating the pupils
1 215908 Nitisinone Capsules, 2 mg, 5 mg, 10 mg, and 20 mg Torrent Pharma Inc. Orfadin (Nitisinone) Capsules 1/9/2023 For the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine

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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