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 |
|---|---|---|---|---|---|
| Aggrastat | Medicure | tirofiban | Nexus | Used to present early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes | 1/1/2023 |
| Duexis | Horizon | ibuprofen / famotidine | Par / Endo | Used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis | 1/3/2023 |
| Suboxone | Indivior | buprenorphine / naloxone | Par / Endo | Used to treat opioid dependence |
1/3/2023 |
| Xyrem | Jazz | sodium oxybate | Hikma | Used to treat cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy | 1/3/2023 |
| Nexavar | Bayer | sorafenib | Teva | Used to treat patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment | 1/3/2023 |
| Amitiza | Sucampo | lubiprostone | Teva | Used to treat adult patients with chronic idiopathic constipation, or opioid-induced constipation in patients with chronic non-cancer pain | 1/3/2023 |
| Flector | IBSA | diclofenac | Yaral | Used to treat pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma | 1/3/2023 |
| Kuvan | Biomarin | sapropterin | Camber / Hetero | Used to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU) | 1/4/2023 |
| Trokendi XR | Supernus | topiramate | Zydus | Used to manage and treat epilepsy and migraine | 1/4/2023 |
| Narcan | Emergent | naloxone | Hikma | Used for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression | 1/4/2023 |
| Cambia | Assertio | diclofenac | Par / Endo | Used to treat pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma | 1/5/2023 |
| Haloette / NuvaRing | Merck | etonogestrel / ethinyl estradiol | Mayne | Used for the prevention of pregnancy in women who elect to use this product as a method of contraception | 1/13/2023 |
| Cambia | Assertio | diclofenac | Camber / Hetero | Used to treat pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma | 1/14/2023 |
| Tenex | Unichem | guanfacine HCL | TWi | Used to treat Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications | 1/23/2023 |
| Theophylline | Akorn | theophylline | Teva | Used to prevent and treat wheezing, shortness of breath, and chest tightness caused by asthma, chronic bronchitis, emphysema, and other lung diseases | 1/27/2023 |
| 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 |
| Namenda | Allergan | memantine HCL | Camber / Hetero | Used to treat moderate to severe dementia of the Alzheimer's type | 1/30/2023 |
| Doryx MPC | Mayne | doxycycline | Mayne | Used to treat many different bacterial infections including acne, urinary and respiratory tract infections, eye infections, gum disease, gonorrhea, chlamydia, and syphilis. It can also be used prevent malaria and treat infections caused by mites, ticks, or lice | 2/15/2023 |
| Cardizem | Bausch | diltiazem | Mayne | Used to treat high blood pressure and to control angina (chest pain) | 2/15/2023 |
| Zonalon | Mylan | doxepin | Teva | Used to treat insomnia (difficulty falling asleep or staying asleep) in people who have trouble staying asleep | 2/17/2023 |
| Latuda | Sunovion | lurasidone | Lupin | Used to treat schizophrenia in patients ≥13 years old. It is also indicated as a monotherapy for the treatment of bipolar depression in patients ≥10 years old, or in combination with lithium or valproate for the treatment of bipolar depression in adults | 2/21/2023 |
| Combigan | AbbVie | brimonidine / timolol | Apotex | Used to treat increased eye pressure from either open-angle glaucoma or ocular hypertension | 2/23/2023 |
| Zyprexa Zydis | Eli Lilly | olanzapine | Apotex | Used in the management of schizophrenia, bipolar 1 disorder, and agitation associated with these disorders | 2/24/2023 |
| Valcyte | Roche | valganciclovir | Camber / Hetero | Used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people who have acquired immunodeficiency syndrome (AIDS) | 3/1/2023 |
| Cystadane | Recordati | betaine | Cosette/ANI | Used to treat homocystinuria in pediatric and adult patients to decrease elevated homocysteine blood levels | 3/2/2023 |
| Axiron | Eli Lilly | testosterone | TWi | Used for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone | 3/2/2023 |
| Ranexa | Gilead | ranolazine | Camber / Hetero | Used to treat chronic angina | 3/3/2023 |
| Bentyl | AbbVie | dicyclomine | Upsher-Smith / CorePharma | Used to treat functional bowel disorder and irritable bowel syndrome | 3/6/2023 |
| Revlimid | Celgene | lenalidomide | Teva | Used to treat patients with multiple myeloma (MM) in combination with dexamethasone | 3/8/2023 |
| Zyvox | Hetero | linezolid | Camber / Hetero | Used to treat infections, including pneumonia, and infections of the skin | 3/9/2023 |
| Revlimid | Celgene | lenalidomide | Natco | Used to treat adult patients with multiple myeloma (MM) in combination with dexamethasone | 3/9/2023 |
| Pylera | AbbVie | bismuth subcitrate potassium / metronidazole / tetracycline | Endo | Used to treat ulcers in the stomach caused by the bacteria H. pylori | 3/10/2023 |
| Aubagio | Sanofi | teriflunomide | Accord | Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults | 3/13/2023 |
| Aubagio | Sanofi | teriflunomide | 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 adults | 3/13/2023 |
| Aubagio | Sanofi | teriflunomide | Teva | Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults | 3/13/2023 |
| Lexiscan | Astellas | regadenoson | Apotex | Used as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress | 3/13/2023 |
| Thyro-Tabs | Alvogen | levothyroxine sodium | Camber / Hetero | Used to treat primary, secondary, and tertiary hypothyroidism | 3/21/2023 |
| Vascepa | Amarin | icosapent | Hikma | Used to reduce the risk of heart attack, stroke, and certain types of heart problems that require treatment in a hospital | 3/21/2023 |
| Protonix | Wyeth | pantoprazole | Camber / Hetero | Used to treat damage from gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 5 years of age and older | 3/23/2023 |
| Adrenalin | Par | epinephrine | American Regent | Used in the emergency treatment of type I allergic reactions, including anaphylaxis | 3/30/2023 |
| Trokendi XR | Supernus | topiramate | Teva | Used to manage and treat epilepsy and migraine | 3/31/2023 |
| Amicar | Clover | aminocaproic acid | Camber / Hetero | Used to treat excessive postoperative bleeding | 3/31/2023 |
