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 |
|---|---|---|---|---|---|
| Dotarem | Guerbet | gadoterate meglumine | Fesenius Kabi | For use in MRI of the brain (intracranial), spine and associated tissues in adults and children (including term neonates) to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity | 10/4/2022 |
| Zovirax | Bausch | acyclovir | Camber / Hetero | Used for the prophylaxis of herpes simplex infections in immunocompromised patients | 10/5/2022 |
| Combigan | AbbVie | brimonidine / timolol | Teva | Used to treat the symptoms of Elevated IOP in patient with Glaucoma or Ocular Hypertension | 10/11/2022 |
| Cardura | Viatris | doxazosin | Apotex | Used to treat hypertension, to lower blood pressure | 10/18/2022 |
| Gilenya | Novartis | fingolimod | Apotex | Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older | 10/19/2022 |
| Gilenya | Novartis | fingolimod | Camber / Hetero | Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older | 10/20/2022 |
| Daliresp | Astra-Zeneca | roflumilast | Camber / Hetero | Used to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis | 10/20/2022 |
| Invega | J&J | paliperidone | Lupin | Used to treat schizophrenia | 10/20/2022 |
| Zytiga | J&J | abiraterone | Apotex | Used to treat patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel | 10/28/2022 |
| Gilenya | Novartis | fingolimod | Glenmark | Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older | 10/31/2022 |
| Aggrastat | Medicure | tirofiban | Nexus | Used to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) | 11/1/2022 |
| Naprelan | Almatica | naproxen | Teva | Used to treat the symptoms of Rheumatoid Arthritis, Osteoarthritis, Ankylosin Spondylitis, Dysmenorrhea, Acute Gout and Pain | 11/1/2022 |
| Esbriet | Genentech | pirfenidone | Camber / Hetero | Used to treat idiopathic pulmonary fibrosis (IPF) | 11/10/2022 |
| Folotyn | Allos | pralatrexate | Fresenius Kabi / Sandoz | Used to treat patients with relapsed or refractory peripheral T-cell lymphoma | 11/14/2022 |
| Denavir | Mylan | penciclovir | Teva | Used to treat recurrent herpes labialis (cold sores) in adults and children 12 years of age or older | 11/14/2022 |
| Zioptan | Akorn | tafluprost | Prasco | Used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension | 11/18/2022 |
| Lupron Depot | AbbVie | leuprolide acetate | Cipla | Used to manage endometriosis, including pain relief and reduction of endometriotic lesions | 11/29/2022 |
| Perforomist | Mylan | formoterol | Lupin | Used for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema | 11/29/2022 |
| Afinitor | Novartis | everolimus | Par / Endo | Used to treat hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor | 11/30/2022 |
| Folotyn | Allos | pralatrexate | Dr. Reddy's Labs | Used to treat patients with relapsed or refractory peripheral T-cell lymphoma | 12/1/2022 |
| Folotyn | Allos | pralatrexate | Teva | Used to treat patients with relapsed or refractory peripheral T-cell lymphoma | 12/1/2022 |
| Banzel | Eisai | rufinamide | Lupin | Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults | 12/5/2022 |
| Folotyn | Allos | pralatrexate | Fresenius Kabi | Used to treat patients with relapsed or refractory peripheral T-cell lymphoma | 12/8/2022 |
| Pennsaid 2% | Horizon | diclofenac | Lupin | Used to treat signs and symptoms of osteoarthritis of the knee(s) | 12/9/2022 |
| Vimpat | UCB | lacosamide | Camber / Hetero | Used to treat partial-onset seizures in patients 4 years of age and older | 12/14/2022 |
| Levothyroxine | Fresenius Kabi | levothyroxine sodium | Hikma | Used to treat hypothyroidism | 12/14/2022 |
| Vimpat | UCB | lacosamide | Fresenius Kabi | Used to treat partial-onset seizures in patients 4 years of age and older | 12/15/2022 |
| Vascepa | Amarin | icosapent | Teva | Used as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and o established cardiovascular disease or o diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.; as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia | 12/15/2022 |
| Emla | Teva | prilocaine / lidocaine | Padagis | Used as a topical anaesthetic for use on: - normal intact skin for local analgesia - genital mucous membranes for superficial minor surgery and as pre-treatment for infiltration anaesthesia |
12/21/2022 |
| Rayos | Horizon | prednisone | Teva | Used as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation; for the treatment of certain endocrine conditions; for palliation of certain neoplastic conditions | 12/23/2022 |
| Hetlioz | Teva | tasimelteon | Teva | Used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) patients 16 years of age and older | 12/29/2022 |
