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 |
|---|---|---|---|---|---|
| Klor-Con | Upsher-Smith | potassium chloride | Hetero / Camber | used to treat patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis | 7/6/2021 |
| Ambien CR | Sanofi | zolpidem | Breckenridge | used to treat insomnia in adults | 7/8/2021 |
| Lescol XL | Novartis | fluvastatin | Lannett | used as an adjunctive therapy with changes to diet to lower cholesterol, slow the progression of heart disease, and reduce the risk of needing procedures to improve blood flow to the heart | 7/12/2021 |
| Kerydin | Anacor | tavaborole | Lupin | used topically to treat onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes | 7/13/2021 |
| Zytiga | Johnson & Johnson | abiraterone | Apotex | used to treat metastatic prostate cancer | 7/14/2021 |
| Feraheme | AMAG/Covis | ferumoxytol | Sandoz | used to treat iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had an unsatisfactory response to oral iron, or who have chronic kidney disease | 7/16/2021 |
| Revatio | Pfizer | sildenafil | Hetero / Camber | used to treat erectile dysfunction (impotence) in men | 7/19/2021 |
| Chantix | Pfizer | varenicline | Apotex | used as an aid to smoking cessation treatment | 7/20/2021 |
| Levitra | Bayer | vardenafil | Alembic | used to treat erectile dysfunction | 7/30/2021 |
| Extina | Mylan | ketoconazole | Xiromed | used topically to treat seborrheic dermatitis in immunocompetent patients 12 years of age and older | 8/2/2021 |
| Lioresal | Novartis | baclofen | Hetero / Camber | used to treat muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease | 8/2/2021 |
| Duexis | Horizon | ibuprofen / famotidine | Alkem | used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications | 8/4/2021 |
| Kloxxado | Hikma | naloxone nasal spray | Hikma | used in an emergency to treat known or suspected opioid overdose for adult and pediatric patients | 8/4/2021 |
| Taysofy | AbbVie | ethinyl estradiol / norethindrone / ferrous fumarate | Amneal | used to prevent pregnancy | 8/5/2021 |
| Isuprel | Bausch & Lomb | isoproterenol | Amring | used for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy | 8/5/2021 |
| Tegretol XR | Novartis | carbamazepine | Upsher-Smith | used as an anticonvulsant and specific analgesic for trigeminal neuralgia | 8/16/2021 |
| Lovenox | Sanofi | enoxaparin | Zydus | used for prophylaxis of deep vein thrombosis in patients undergoing abdominal, hip or knee replacement surgery | 8/17/2021 |
| Levophed | Hospira | noreinephrine bitartrate | Breckenridge | used to restore blood pressure control in certain acute hypotensive states | 8/20/2021 |
| Clindagel | Bausch & Lomb | clindamycin | Solaris | used topically to treat acne vulgaris | 8/23/2021 |
| Sodium Acetate | Pfizer | sodium acetate | Milla | used as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake | 8/26/2021 |
| Axiron | Eli Lilly | testosterone | Acrux / Dash Pharma | used for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone | 8/26/2021 |
| Northera | Lundbeck | droxidopa | Aurobindo | used to treat orthostatic dizziness, light headedness in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy | 8/27/2021 |
| CellCept | Roche | mycophenolate | Lannett | used for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immune-suppressants | 8/30/2021 |
| Librax | Bausch & Lomb | chlordiazepoxide / clidinium bromide | Dr. Reddy's | used to control emotional and somatic factors in gastrointestinal disorders. It may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis | 8/31/2021 |
| Jadenu | Novartis | deferasirox | Hetero / Camber | used to treat iron overload caused by blood transfusions in adults and children at least 2 years old; also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old | 8/31/2021 |
| Paxil O.S. | Glaxo | paroxetine | ANI / Novitium | used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic stress disorder | 9/10/2021 |
| Duexis | Horizon | ibuprofen / famotidine | Lupin | used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications | 9/15/2021 |
| Trisenox | Teva | arsenic trioxide | Amneal | used for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression | 9/16/2021 |
| Bystolic | AbbVie | nebivilol | ANI | used to treat hypertension, to lower blood pressure and may be used alone or in combination with other antihypertensive agents | 9/17/2021 |
| Bystolic | AbbVie | nebivilol | Hetero / Camber | used to treat hypertension, to lower blood pressure and may be used alone or in combination with other antihypertensive agents | 9/17/2021 |
| Chantix | Pfizer | varenicline | Par | used to aid smoking cessation treatment | 9/22/2021 |
| Taxotere | Sanofi | docetaxel | Xiromed / Insud | used to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy | 9/27/2021 |
| Northera | Lundbeck | droxidopa | Lupin | used to treat orthostatic dizziness, light headedness in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy | 9/28/2021 |
| Absorica | Sun | isotretinoin | Mayne | used to treat severe recalcitrant nodular acne | 9/29/2021 |
| Butrans | Purdue | buprenorphine | Apotex | used to manage pain severe enough to require daily, around-the- clock, long-term opioid treatment and for which alternative treatment options are inadequate | 9/30/2021 |
