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 |
|---|---|---|---|---|---|
| Hetlioz | Vanda | tasimelteon | Apotex | Used to treat non-24 hour sleep-wake disorder in adult patients and for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome in patients ≥16 years old. | 1/05/2024 |
| Prolensa | Bausch & Lomb | bromfenac ophthalmic solution, 0.07% | Lupin | Used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. | 1/09/2024 |
| Chantix | PF Prism | varenicline | Lupin | Used as an aid to smoking cessation treatment. | 1/10/2024 |
| Chantix | PF Prism | varenicline | Apotex | Used as an aid to smoking cessation treatment. | 1/15/2024 |
| Korlym | Corcept Therapeutics | mifepristone | Teva | Used to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type II diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. | 1/19/2024 |
| Orfadin | Swedish Orphan | nitisinone | Eton | Used to treat hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. | 2/02/2024 |
| Alphagan P Ophthalmic Solution | AbbVie | brimonidine tartrate | Alembic | Used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. | 2/06/2024 |
| Invega | Janssen | paliperidone | Camber | Used to treat schizophrenia, schizoaffective disorder as monotherapy, and as an adjunct to mood stabilizers and/or antidepressants. | 2/12/2024 |
| Entereg | Cubist | alvimopan | Hikma | Used to help restore normal bowel function in patients who have just had bowel resection surgery. | 2/13/2024 |
| Pradaxa | Boehringer Ingelheim | dabigatran etexilate | Apotex | Used to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days, to reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated, for the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery. | 2/13/2024 |
| Ganirelix Acetate | Organon | ganirelix acetate | Lupin | Used to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation. | 2/15/2024 |
| BiCNU | Avent Lifesciences | carmustine | Alembic | Used alone or together with other medicines to treat certain type of brain tumors (e.g., glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors), cancer of the lymph system (e.g., Hodgkin's disease, non-Hodgkin's lymphoma), and a certain type of cancer in the bone marrow (e.g., multiple myeloma). | 2/21/2024 |
| Cytoxan | Baxter | cyclophosphamide | Fresenius Kabi | Used to treat cancer of the ovaries, breast, blood and lymph system, and nerves (mainly in children). Also used for retinoblastoma (a type of eye cancer mainly in children), multiple myeloma (cancer in the bone marrow), and mycosis fungoides (tumors on the skin). | 2/28/2024 |
| Trileptal | Novartis | oxcarbazepine | Camber | Used for adults as monotherapy or adjunctive therapy in the treatment of partial-onset seizures. Pediatrics use as monotherapy in the treatment of partial-onset seizures in children 4 to 16 years of age, and as adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years of age. |
2/29/2025 |
| Lipitor | Pfizer | atorvastatin | Camber | Used to lower lipid levels and reduce the risk of cardiovascular disease including myocardial infarction and stroke. | 2/29/2024 |
| Vascepa | Amarin | icosapent | Camber | Used as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalizing in adult patients with elevated triglycerides and established cardiovascular disease or who have diabetes mellitus and ≥2 other risk factors for cardiovascular disease. It is also indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. | 3/08/2024 |
| Gralise | Chemo Research | gabapentin | Camber | Used to manage Postherpetic Neuralgia (PHN). | 3/18/2024 |
| Theophylline | Bausch | theophylline | Camber | Used to treat symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases. | 3/20/2024 |
| Duexis | Horizon Therapeutics | ibuprophen / famotidine | Endo | Used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis while decreasing the risk of developing ulcers of the stomach and upper intestines people may experience from ibuprofen alone. | 3/26/2024 |
| Zomig | IPR Pharmaceuticals | zolmitriptan | Alembic | Used for the acute treatment of migraine with or without aura in adults. | 3/28/2024 |
| Zyloprim | Casper Pharma | allopurinol | Camber | Used to manage patients with signs and symptoms of primary or secondary gout, the management of patients with conditions requiring therapies which cause elevations of serum and urinary uric acid levels, and the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds specific thresholds. | 3/29/2024 |
