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 |
|---|---|---|---|---|---|
| Carnitor | Leadiant | levocarnitine | Hikma | Used for the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. It is also indicated to prevent and treat carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. | 10/5/2023 |
| Mydayis | Takeda | amphetamine / dextroamphetamine | Teva | Used to treat attention deficit hyperactivity disorder (ADHD) in patients 13 years and older. | 10/10/2023 |
| Jadenu Sprinkle | Novartis | deferasirox | Camber | Used to treat chronic iron overload (1) due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older, and (2) in patients 10 years of age and older with non-transfusion-dependent thalassemia syndromes exhibiting elevated liver and serum iron concentrations. | 10/12/2023 |
| Azopt | Novartis | brinzolamide | Padagis | Used to decrease elevated intraocular pressure (IOP) in adult patients with ocular hypertension or open-angle glaucoma, as monotherapy in patients unresponsive to betablockers or in patients in whom beta-blockers are contraindicated, or as adjunctive therapy to betablockers. | 10/13/2023 |
| Prezista | Johnson & Johnson | darunavir | Camber | Used to treat HIV-1 infection in adult and pediatric patients 3 years of age and older. | 10/18/2023 |
| Tranexamic Acid Sodium Chloride Injection | Exela | tranexamic acid | Amneal | Used for heavy menstrual bleeding and short-term prevention in patients with hemophilia; this includes tooth extractions in patients with hemophilia as well as menorrhagia in these patients. | 10/19/2023 |
| Votrient | Novartis | pazopanib | Apotex | Used to treat adults with advanced renal cell carcinoma (RCC). | 10/20/2023 |
| Afinitor | Novartis | everolimus | Teva | Used to treat patients with advanced hormone receptor—positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; progressive neuroendocrine tumors (NETs) of pancreatic origin; and progressive, well-differentiated, non-functional NETs of gastrointestinal or lung origin that are unresectable; and renal angiomyolipoma and tuberous sclerosis complex. | 10/23/2023 |
| Inspra | Pfizer | eplerenone | Camber | Used to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction and for the treatment of hypertension, to lower blood pressure. | 10/25/2023 |
| Calcium Gluconate | Fresenius Kabi | calcium gluconate | Somerset | Used to treat acute symptomatic hypocalcemia in pediatric and adult patients. | 10/27/2023 |
| Diastat AcuDial | Bausch Health | diazepam | Novel Laboratories (Lupin) | Used to control seizures (eg, seizure clusters, acute repetitive seizures) in patients who have epilepsy. | 11/2/2023 |
| Mitigare | Hikma | colchicine | Par | Used for prophylaxis of gout flares in adults. | 11/2/2023 |
| Livalo | Kowa | pitavastatin | Teva | Used to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia. | 11/2/2023 |
| Livalo | Kowa | pitavastatin | Upsher-Smith Labs | Used to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia. | 11/6/2023 |
| Zemuron | Organon | rocuronium bromide | Caplin Steriles (Lupin) |
Used for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. | 11/8/2023 |
| Jadenu Sprinkle | Novartis | deferasirox | Teva | Used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. | 11/10/2023 |
| Locoid | Bausch Health | hydrocortisone butyrate | J. Molner | Used to treat symptoms of dermatoses. | 11/15/2023 |
| Forteo | Eli Lilly | teriparatide | Teva | Used to treat osteoporosis. | 11/17/2023 |
| Forteo | Eli Lilly | teriparatide | Apotex | Used to treat osteoporosis. | 11/21/2023 |
| Pepcid | Johnson & Johnson | famotidine | Camber | Used to treat active duodenal ulcer, active gastric ulcer, GERD, erosive esophagitis due to GERD, treatment of pathological hypersecretory conditions, reduction of the rusk of DU recurrence in adults. Used to treat peptic ulcer disease, GERD in pediatric patients 1 year or older. Used to treat GERD for pediatric patients less than 1 year of age. | 11/27/2023 |
| Vascepa | Amarin | icosapent | Amneal / Strides | Used as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. | 12/1/2023 |
| Turqoz | Wyeth | norgestrel / ethinyl estradiol | Lupin | Used to prevent pregnancy. | 12/1/2023 |
| Dexamethasone | Hikma | dexamethasone | Apotex | Used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, kidney problems, skin conditions, and flare-ups of multiple sclerosis. | 12/12/2023 |
| Vidaza | Bristol-Myers Squibb | azacitidine | Apotex | Used for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. | 12/13/2023 |
| Cetrotide | Merck Serono | cetrorelix | Teva | Used to prevent premature ovulation (early release of eggs from the ovary). It is given to women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce more eggs). | 12/14/2023 |
| Immphentiv | Hikma | phenylephrine | Hikma | Used to increase blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. | 12/19/2023 |
