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 |
|---|---|---|---|---|---|
| Apriso | Sunovion | mesalamine | Teva | Used to maintain remission of ulcerative colitis in patients 18 years of age and older | 10/1/2021 |
| Afinitor | Novartis | everolimus | Breckenridge | Used to treat postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole | 10/1/2021 |
| Afinitor | Novartis | everolimus | Biocon | Used to treat postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole | 10/4/2021 |
| BiCNU | Emcure | carmustine | Dr. Reddy's | Used to treat certain types of brain tumors; glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma and metastatic brain tumors | 10/15/2021 |
| Doxil | Baxter | doxorubicin | Padagis | Used to treat Ovarian Cancer, AIDS-related Kaposi’s Sarcoma and Multiple Myeloma | 10/21/2021 |
| Emerphed | Nexus | ephedrine sulfate | Par | Used to treat clinically important hypotension occurring in the setting of anesthesia | 10/26/2021 |
| Decadron | Merck | dexamethasone | Amneal | Used to treat several medical conditions, including respiratory complications associated with COVID-19 | 10/27/2021 |
| Akovaz | Exela | ephedrine | Dr. Reddy's | Used to treat clinically important hypotension occurring in the setting of anesthesia | 10/29/2021 |
| Antara | Lupin | fenofibrate | Lupin | Used as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia | 11/3/2021 |
| Desferal | Novartis | deferoxamine | Apotex | Used to treat acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias | 11/10/2021 |
| Samsca | Otsuka | tolvaptan | Camber / Hetero | Used to treat hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances | 11/10/2021 |
| Targretin | Eisai | bexarotene | Teva | Used to treat cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy | 11/11/2021 |
| Zaditor | Alcon | ketotifen | Bayshore | Used to treat itchy eyes | 11/15/2021 |
| Zomig | iPR Pharmaceuticals | zolmitriptan | Padagis | Used to treat migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age) | 11/16/2021 |
| Zoloft | Pfizer | sertraline | Camber / Hetero | Used to treat major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder (SAD), and post-traumatic stress disorder (PTSD) | 11/19/2021 |
| Epiduo Forte | Galderma | adapalene / benzoyl peroxide | Teva | Used to treat acne vulgaris | 12/1/2021 |
| Brovana | Sunovion | arformoterol | Teva | Used for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema | 12/6/2021 |
| Diovan | Novartis | valsartan | Dr. Reddy's | Used to lower blood pressure, treat heart failure, or increase chances of survival after a heart attack | 12/9/2021 |
| Venlafaxine ER | Osmotica | venlafaxine | Dr. Reddy's | Used to treat Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD) with or without agoraphobia | 12/9/2021 |
| Daraprim | Vyera | pyrimethamine | Teva | Used to treat acute malaria in combination with other antimalarials only | 12/15/2021 |
| Carbaglu | Recordati | carglumic acid | Eton / ANI | Useed to treat acute and chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency | 12/20/2021 |
| Marcaine | Hospira | bupivacaine | Hikma | Used in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures | 12/20/2021 |
| Northera | Lundbeck | droxidopa | Camber / Hetero | Used to treat low blood pressure that causes severe dizziness or a light-headed feeling | 12/21/2021 |
| Narcan | Adapt | naloxone HCl | Teva | Used to treat an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond | 12/22/2021 |
| Sutent | Pfizer | sunitinib | Teva | Used to treat advanced renal cell carcinoma | 12/22/2021 |
| Narcan | Adapt | naloxone HCl | Sandoz | Used to treat an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond | 12/22/2021 |
| Butrans | Purdue | buprenorphine | Teva | Used to manage pain severe enough to require daily, around-the- clock, long-term opioid treatment and for which alternative treatment options are inadequate | 12/27/2021 |
