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 | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Amitiza | Takeda | Lubiprostone | Par | Used to treat chronic idiopathic constipation, as well as opioid-induced constipation in adult with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation. The drug is also used to treat irritable bowel syndrome with constipation in women at least 18 years old | 1/4/2021 |
| Firazyr | Takeda | icatibant | Apotex | Used to treat acute attacks of hereditary angioedema |
1/6/2021 |
| Zytiga | Johnson & Johnson | abiraterone | Amneal | Used to treat metastatic prostate cancer | 1/8/2021 |
| Uloric | Takeda | febuxostat | Dr. Reddy's Labs | Used for the chronic management of hyperuricemia in adult patients with gout |
1/11/2021 |
| Tecfidera | Biogen | dimethyl fumarate | TWi | Used to treat relapsing forms of multiple sclerosis | 1/11/2021 |
| Albenza | Amneal | albendazole | Cost Plus | Used to treat parasitic infections such as hydatid disease and neurocysticercosis | 1/14/2021 |
| NuvaRing | Merck | etonogestrel / ethyl estradiol | Teva | Used by women to prevent pregnancy | 1/14/2021 |
| Effexor XR | Wyeth | venlafaxine | Hetero | Used to treat major depressive disorder, anxiety, and panic disorder | 1/21/2021 |
| Minipress | Pfizer | prazosin | ANI | Used to treat hypertension, to lower blood pressure | 2/1/2021 |
| Sabril | Lundbeck | vigabatrin | Dr. Reddy's Labs | Used to treat refractory complex partial seizures and infantile spasms | 2/2/2021 |
| Thorazine | Glaxo | chlorpromazine | Lannett | Used to treat psychotic disorders such as schizophrenia or manic-depression in adults | 2/8/2021 |
| AndroGel 1.62% | Unimed | testosterone | Teva | Used for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone | 2/12/2021 |
| Noxafil | Merck | posaconazole | Lupin | Used for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy | 2/17/2021 |
| Xeloda | Roche | capecitabine | Dr. Reddy's Labs | Used to treat adjuvant colon cancer, metastatic colorectal & breast cancer | 2/17/2021 |
| Northera | Lundbeck | droxidopa | Hetero | Used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH) | 2/19/2021 |
| Prevacid SoluTab | Takeda | lansoprazole | Dr. Reddy's | Used to treat certain stomach and esophagus problems (such as acid reflux, ulcers) | 2/22/2021 |
| Northera | Lundbeck | droxidopa | Hikma | Used to treat symptoms of low blood pressure when standing, caused by a certain medical condition (neurogenic orthostatic hypotension-NOH) | 3/2/2021 |
| Depen | Mylan | penicillamine | Lupin | Usedto treat Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy | 3/2/2021 |
| Azopt | Novartis | brinzolamide | Teva | Used to treat high pressure inside the eye due to ocular hypertension and open-angle glaucoma | 3/8/2021 |
| Alinia | Romark | nitazoxamide | Lupin | Used in the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 12 years of age and older | 3/10/2021 |
| Foscavir | Teva | foscarnet | Fresenius Kabi | Used to treat CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and in Combination therapy with Foscarnet Sodium Injection and ganciclovir for patients who have relapsed after monotherapy with either drug | 3/15/2021 |
| Lopid | Pfizer | gemfibrozil | Hetero | Used together with proper diet to treat very high cholesterol and triglyceride levels and raise “good” cholesterol (HDL) in the blood | 3/30/2021 |
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