Abbreviated New Drug Applications and 505(b)(2) Applications
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 |
| Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Noxafil | Merck | posaconazole | Hikma | Used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection | 4/3/2023 |
| Prolixin | Apothecon | fluphenazine | Upsher Smith | Used to treat schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility | 4/3/2023 |
| Noxafil | Merck | posaconazole | Endo | Used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection | 4/4/2023 |
| Bentyl | AbbVie | dicyclomine | TWi | Used to treat functional bowel disorder and irritable bowel syndrome | 4/2023? |
| K-Tab | AbbVie | potassium chloride | TWi | Used for prophylaxis and treatment of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient | 4/2023? |
| Combigan | AbbVie | brimonidine / timolol | Upsher Smith | Used to treat increased pressure in the eye caused by glaucoma or a condition called hypertension of the eye | 4/13/2023 |
| Depo-Testosterone | Pfizer | testoterone cypionate | Xiromed | Used as replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone | 4/13/2023 |
| Argatroban | Novartis | argatroban | Par / Endo | Used for prophylaxis or treatment of thrombosis in adult patients with heparin- induced thrombocytopenia (HIT) | 4/17/2023 |
| Lexiscan | Astellas | regadenoson | Hikma | Is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress | 4/17/2023 |
| Daliresp | AstraZeneca | roflumilast | Camber / Hetero | Used to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations | 4/21/2023 |
| Remodulin | United Therapeutics | treprostinil | Dr. Reddy's Labs | Used to treat pulmonary arterial hypertension (PAH) | 4/21/2023 |
| Zyflo CR | Chiesi | zileuton | Camber / Hetero | Is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older | 4/26/2023 |
| Delestrogen | Par | estradiol valerate | Xiromed | Used to treat moderate to severe vasomotor symptoms associated with the menopause | 5/1/2023 |
| Phernegan | Mylan | promethazine | Camber / Hetero | Used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes; also prevents motion sickness, and treats nausea and vomiting or pain after surgery; also used as a sedative or sleep aid | 5/3/2023 |
| Lexiscan | Astellas | regadenoson | Dr. Reddy's Labs | Is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress | 5/5/2023 |
| Syprine | Bausch | trientine HCl | Camber / Hetero | Used to treat patients with Wilson’s disease who are intolerant of penicillamine | 5/8/2023 |
| Cystadane | Recordati | betaine anhydrous | Eton | Used to treat homocystinuria | 5/10/2023 |
| Prezista | Johnson & Johnson | darunavir | Teva | Used to treat human immunodeficiency virus (HIV) in children age 3 or above and adults with HIV-1 infection | 6/1/2023 |
| Prezista | Johnson & Johnson | darunavir | Lupin | Used to treat human immunodeficiency virus (HIV) in children age 3 or above and adults with HIV-1 infection | 6/3/2023 |
| Mexitil | Boehringer Ingelheim | mexiletine HCl | Camber / Hetero | Used to treat documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening | 6/6/2023 |
| Iressa | AstraZeneca | gefitinib | Apotex | Used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK | 6/14/2023 |
| Treanda | Teva | bendamustine | Apotex | Used to treat chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen | 6/14/2023 |
| Vasostrict | Endo | vasopressin | Fresenius Kabi | Used to treat increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines | 6/14/2023 |
| Vimpat | UCB | lacosamide | Apotex | Used to treat partial-onset seizures in patients aged one month and older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients aged four years and older | 6/14/2023 |
| Dexilant | Takeda | dexlansoprazole | Par / Endo | Used to treat erosive esophagitis and heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) | 6/15/2023 |
| Thiamine | Fresenius Kabi | thiamine HCl | Lupin | Used to treat thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety | 6/19/2023 |
| Iressa | AstraZeneca | gefitinib | Teva | Used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK | 6/21/2023 |
| Banzel | Eisai | rufinamide | Lupin | Used for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in pediatric patients one year of age and older and adults | 6/23/2023 |
| Kinevac | Bracco Diagnostics | sincalide | Fresenius Kabi | Used to stimulate gallbladder contraction or pancreatic secretion during diagnostic tests, and accelerate fluoroscopy and x-ray examination of the intestinal tract | 6/21/2023 |
| Vancocin | ANI | vancomycin | Amneal | Used to treat serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci; also indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs | 6/2023? |
| Noxafil | Merck | posaconazole | Endo / Par | Indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy. | 6/29/2023 |
| Midazolam | Inforlife | Midazolam in 0.9% sodium chloride | Hikma | Used for continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting | 6/30/2023 |
