Abbreviated New Drug Applications and 505(b)(2) Applications
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.
| Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) | Indication | Launch Date |
| Victoza | Novo-Nordisk | liraglutide | Lupin | Used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older, with type 2 diabetes mellitus. | 10/3/2025 |
| Ravicti | Amgen | glycerol phenylbutyrate | Endo | Used as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. | 10/20/2025 |
| Naropin | Fresenius Kabi | ropivacaine | Glenmark | Used as a local or regional anesthesia for surgery and for acute pain management. | 10/23/2025 |
| Ravicti | Amgen | glycerol phenylbutyrate | Lupin | Used as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. | 10/24/2025 |
| Brekiya | Amneal | dihydroergotamine mesylate | Amneal | Used for the acute treatment of migraine with or without aura and acute cluster headaches in adults. | 10/27/2025 |
| Restasis | AbbVie | cyclosporine | Teva | Used to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (chronic dry eye). | 10/28/2025 |
| Dalvance | AbbVie | dalbavancin | Teva | Used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults and children. | 10/29/2025 |
| Tasigna | Novartis | nilotinib | Camber | Used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) for pediatric patients greater than or equal to 1 year of age and adults, based on various stages of disease diagnosis, disease progression, and previous treatment results. | 12/2/2025 |
| Gleevec | Novartis | imatinib mesylate | Hetero | Used to treat specific types of leukemia, gastrointestinal tumors, and other rare cancers. | 12/4/2025 |
| Adzenys XR-ODT | Neos | amphetamine | Teva | Used to treat ADHD. | 12/8/2025 |
| Tyzavan | Hikma | vancomycin | Hikma | Used to treat the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: (i) septicemia; (ii) infective endocarditis; (iii) skin and skin structure infections; (iv) bone infections; and (v) lower respiratory tract infections. | 12/8/2025 |
| Leucovorin Calcium for Injection | Hospira | leucovorin calcium for injection | Glenmark | Used as a combination therapy with the cancer medication methotrexate to protect healthy cells and reduce toxic side effects. It is also used in the treatment of anemia. | 12/11/2025 |
| Javadin | Azurity | clonidine hydrochloride | Azurity | Used to treat hypertension in adult patients to lower blood pressure. | 12/18/2025 |
| Epinephrine Injection | BPI | epinephrine injection | Glenmark | Used as the first-line and immediate emergency treatment for anaphylaxis. | 12/23/2025 |
