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 |
|---|---|---|---|---|---|
| Adderall XR | Takeda | amphetamine | Camber / Hetero | Used to treat attention deficit hyperactivity disorder (ADHD) | 1/4/2022 |
| Cuvposa | Merz | glycopyrrolate | Endo | Used to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy) | 1/4/2022 |
| Protopic | LEO | tacrolimus | Mayne | Used to treat atopic dermatitis |
1/12/2022 |
| Vasostrict | Endo | vasopressin | Eagle | Used to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines | 1/17/2022 |
| Colcrys | Takeda | colchicine | Camber / Hetero | Used to treat and for prophylaxis of gout flares in adults and Familial Mediterranean fever (FMF) in adults and children 4 years or older | 1/19/2022 |
| Combigan | AbbVie | brimodine / timolol | Apotex | Used to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension | 1/19/2022 |
| Purified Cortrophin gel | ANI | repository corticotropin | ANI | Used to treat certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), and excess urinary protein due to nephrotic syndrome | 1/24/2022 |
| Nitropress | Hospira | sodium nitroprusside | Xiromed | Used to treat the symptoms of acute heart failure, hypertensive crisis and controlled hypotension during surgery | 1/24/2022 |
| Focalin XR | Novartis | dexmethylphenidate | Camber / Hetero | Used to treat attention deficit hyperactivity disorder (ADHD) | 1/26/2022 |
| Alphagan P | AbbVie | brimonidine | Apotex | Used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension |
1/31/2022 |
| Pemfexy | Eli Lilly | pemetrexed | Eagle | Used in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non- squamous, non-small cell lung cancer (NSCLC) | 2/1/2022 |
| Vasostrict | Endo/Par | vasopressin | American Regent | Used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines | 2/3/2022 |
| Vasopressin RTU | Endo | vasopressin | Par | Used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines | 2/7/2022 |
| Restasis | AbbVie | cyclosporine | Apotex | Used to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca | 2/7/2022 |
| Cubicin | Merck | daptomycin | Apotex | Used to treat complicated skin and skin structure infections (cSSSI). It is also used to treat infections in the bloodstream (bacteremia), including right-sided infective endocarditis | 2/7/2022 |
| Vasostrict | Endo | vasopressin | Dr. Reddy's Labs | Used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines | 2/9/2022 |
| Emend | Merck | fosaprepitant | Camber / Hetero | Used to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin; delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) | 2/9/2022 |
| AmBisome | Astellas | amphotericin B liposome | Sun | Used for empirical therapy for presumed fungal infection in febrile, neutropenic patients; treatment of cryptococcal meningitis in HIV-infected patients; treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections; and treatment of visceral leishmaniasis | 2/15/2022 |
| Digoxin | Almirall | lanoxin | Aurobindo | Used to treat mild to moderate heart failure in adults; increases myocardial contractility in pediatric patients with heart failure; and for the control of ventricular response rate in adult patients with chronic atrial fibrillation | 2/21/2022 |
| Compazine | Glaxo | prochlorperazine edisylate | Cosette | Used to control severe nausea and vomiting. Prochlorperazine edisylate is also used for the treatment of schizophrenia | 2/22/2022 |
| Epaned O.S. | Azurity | enalapril | Camber / Hetero | Used for the treatment of hypertension, to lower blood pressure in adults and children older than one month | 2/25/2022 |
| Naftin | Sebela | naftifine | Xiromed | Used for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum | 2/25/2022 |
| Renagel | Genzyme | sevelamer | Lupin | Used for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis | 3/1/2022 |
| Apokyn | Supernus | apomorphine | TruPharma | Used to treat loss of control of body movements in people with advanced Parkinson's disease | 3/1/2022 |
| Myfortic | Novartis | mycophenolate | TWi | Used for the prophylaxis of organ rejection in adult patients receiving a kidney transplant | 3/1/2022 |
| Revlimid | Celgene | lenalidomide | Natco / Teva | Used in adults for the treatment of multiple myeloma in combination with the medicine dexamethasone, certain myelodysplastic syndromes, and mantle cell lymphoma following specific prior treatment |
3/7/2022 |
| Rezipres | Eton | ephedrine | Eton / XGEN Pharms | Used to treat clinically important hypotension occurring in the setting of anesthesia | 3/14/2022 |
| Tobradex | Novartis | dexamethasone / tobramycin | Padagis | Used for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists | 3/21/2022 |
| Advair Diskus | Glaxo | fluticasone / salmeterol | Teva | Used for the twice-daily treatment of asthma in patients aged 4 years and older; of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema | 3/23/2022 |
| Zipsor | Assertio | diclofenac | Teva | Used to relieve mild to moderate acute pain in adult and pediatric patients 12 years of age and older |
3/24/2022 |
