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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 2024*

 

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+
13 216361 Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) Dr. Reddy's Laboratories SA Lumify (Brimonidine Tartrate) Ophthalmic Solution 2/16/2024 Relieves redness of the eye due to minor eye irritations
12 216103 Nitroglycerin Ointment USP, 0.4% Dr. Reddy's Laboratories SA Rectiv (Nitroglycerin) Ointment 2/16/2024 For the treatment of moderate to severe pain associated with chronic anal fissure
11 215574 Ospemifene Tablets, 60 mg Hetero Labs Limited Unit V Osphena (Ospemifene) Tablets 2/13/2024 For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause; for the treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause
10 217123 Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg Aurobindo Pharma Limited Emflaza (Deflazacort) Tablets 2/9/2024 For the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
9 216899 Hydromorphone Hydrochloride Injection USP, 0.2 mg/mL, 0.5 mg/0.5 mL,1 mg/mL, 2 mg/mL Single-Dose Prefilled Syringes Hikma Pharmaceuticals USA, Inc. Dilaudid (Hydromorphone) Hydrochloride Injection 2/9/2024 For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate
8 209986 Cobicistat Tablets, 150 mg Mylan Laboratories Limited Tybost (Cobicistat) Tablets 2/4/2024 For the treatment of HIV-1 infection in adults and in pediatric patients
7 211239 Bromfenac Ophthalmic Solution, 0.075% Lupin Limited BromSite (Bromfenac) Ophthalmic Solution 2/2/2024 For the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery
6 205904 Dronedarone Tablets USP, 400 mg Lupin Inc. Multaq (Dronedarone) Tablets 1/31/2024 To reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF
5 214925 Pimavanserin Capsules, 34 mg MSN Laboratories Private Limited Nuplazid (Pimavanserin) Capsules 1/16/2024 For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis
4 214502 Pimavanserin Tablets, 10 mg Zydus Pharmaceuticals (USA) Inc. Nuplazid (Pimavanserin) Capsules 1/16/2024 For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis
3 214493 Pimavanserin Capsules, 34 mg Zydus Pharmaceuticals (USA) Inc. Nuplazid (Pimavanserin) Capsules 1/16/2024 For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis
2 208443 Fidaxomicin Tablets, 200 mg Actavis Laboratories FL, Inc. Dificid (Fidaxomicin) Tablets 1/16/2024 For the treatment of C. difficile-associated diarrhea
1 203640 Nilotinib Capsules, 50 mg, 150 mg, 200 mg Apotex, Inc. Tasigna (Nilotinib) Capsules 1/5/2024 For the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib; pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor therapy

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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