Abbreviated New Drug Applications and 505(b)(2) Applications
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 |
| Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Camcevi | Accord | leuprolide | Accord | Used in men to treat the symptoms of prostate cancer; used in women to treat symptoms of endometriosis or uterine fibroids | 4/4/2022 |
| Lyrica | Pfizer | pregabalin | Apotex | Used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury | 4/4/2022 |
| Solu-Medrol | Pfizer | methylprednisolone | Dr. Reddy's | Used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders | 4/5/2022 |
| Merzee | AbbVie | ethinyl estradiol / norethindrone / ferrous fumarate | Lupin | Used to prevent pregnancy | 4/7/2022 |
| Cytotec | Pfizer | misoprostol | ANI | Used to prevent stomach ulcers while you take NSAIDs (such as aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers | 4/11/2022 |
| Abraxane | Celgene | paclitaxel | Apotex | Used to treat metastatic breast cancer, non-small cell lung cancer and adenocarcinoma of the pancreas | 4/12/2022 |
| Combigan | AbbVie | brimonidine / timolol | Sandoz | Used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (such as ocular hypertension) | 4/14/2022 |
| Veltin | Almirall | clindamycin/tretinoin | Solaris | Used to treat acne | 4/14/2022 |
| Abraxane | AbbVie | paclitaxel | TWi | Used to treat metastatic breast cancer, non-small cell lung cancer and adenocarcinoma of the pancreas | 4/18/2022 |
| Vimpat | UCB | lacosamide | Breckenridge | Used to prevent and control seizures | 4/19/2022 |
| Velcade | Takeda | bortezomib | Baxter | Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) | 4/29/2022 |
| Velcade | Takeda | bortezomib | Fresenius Kabi | Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) | 4/29/2022 |
| Velcade | Takeda | bortezomib | Apotex | Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) | 5/2/2022 |
| Progesterone | Teva | progesterone | Xiromed | Used to prevent endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets | 5/2/2022 |
| Velcade | Takeda | bortezomib | Aurobindo | Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) | 5/3/2022 |
| Velcade | Takeda | bortezomib | Zydus | Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) | 5/3/2022 |
| Velcade | Takeda | bortezomib | Gland | Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) | 5/4/2022 |
| Velcade | Takeda | bortezomib | Hospira | Used to treat certain types of cancer (such as multiple myeloma, mantle cell lymphoma) | 5/4/2022 |
| Reyataz | Bristol-Myers Squibb | atazanavir | Hetero / Camber | Used with other HIV medications for infants and children to help control HIV infection | 5/11/2022 |
| Esbriet | Genentech | pirfenidone | Teva | Used to treat idiopathic pulmonary fibrosis (IPF) | 5/12/2022 |
| Esbriet | Genentech | pirfenidone | Sandoz | Used to treat idiopathic pulmonary fibrosis (IPF) | 5/13/2022 |
| Transderm Scop | Baxter | scopolamine | Teva | Used to prevent nausea and vomiting caused by motion sickness or recovery from anesthesia and surgery | 5/13/2022 |
| Atripla | Gilead | efavirenz / emtricitabine / tenofovir | Hetero / Camber | Used alone or with other HIV medications to help control HIV infection | 5/16/2022 |
| Abreva | Glaxo | docosanol | Cosette | Used to treat "cold sores/fever blisters" (herpes labialis) | 5/24/2022 |
| Fosrenol | Takeda | lanthanum | Teva | Used to lower phosphate levels in patients with end stage kidney disease | 5/26/2022 |
| Ampyra | Acorda | dalfampridine | Teva | Used to help improve walking in adults with multiple sclerosis (MS) | 6/1/2022 |
| Lyvispah | Amneal | baclofen | Amneal | Used to treat muscle stiffness, spasms, and pain from multiple sclerosis | 6/1/2022 |
| Pepcid | Johnson & Johnson | famotidine | Hetero / Camber | Used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion) | 6/1/2022 |
| Trileptal | Novartis | oxcarbazepine | Hetero / Camber | Used to treat the symptoms of seizures (convulsions) | 6/2/2022 |
| CellCept | Roche | mycophenolate | Teva | Used to prevent rejection (antirejection medicine) in people who have received a kidney, heart or liver transplant | 6/3/2022 |
| Viibryd | AbbVie | vilazodone | Apotex | Used to treat major depressive disorder (MDD) | 6/6/2022 |
| Truvada | Gilead | emtricitabine / tenofovir | Hetero / Camber | Used to treat human immunodeficiency virus (HIV) and hepatitis B virus infection | 6/17/2022 |
| Epiduo Forte | Galderma | adapalene | Padagis | Used to treat the symptoms of Acne Vulgaris | 6/21/2022 |
| Narcan | Adapt | naloxone | Padagis | Used to treat a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond | 6/21/2022 |
| Samsca | Otsuka | tolvaptan | Apotex | Used to treat hyponatremia (low levels of sodium in the blood) in people who have heart failure (condition in which the heart cannot pump enough blood to all parts of the body), syndrome of inappropriate antidiuretic hormone (SIADH; condition in which the body produces too much of a certain natural substance that causes the body to retain water) or other conditions | 6/22/2022 |
| Esbriet | Genentech | pirfenidone | Alembic | Used to treat idiopathic pulmonary fibrosis (IPF) | 6/27/2022 |
