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 |
|---|---|---|---|---|---|
| Prolixin | Bristol-Myers Squibb | fluphenazine | Amneal | Used to treat schizophrenia | 7/10/2020 |
| Nicorette Lozenges | Glaxo | nicotine polacrilex | Dr. Reddy's | Used to aid in smoking cessation in adults | 7/14/2020 |
| Cubicin | Merck | daptomycin | Sandoz | Used to treat adult patients with complicated skin and skin structure infections | 7/13/2020 |
| Mexitil | Boehringer Ingelheim | mexiletine | Lannett | Used to treat documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening | 7/23/2020 |
| Cyklokapron | ANI | tranexamic acid | Apotex | Used to treat cyclic heavy menstrual bleeding | 7/29/2020 |
| Zyclara | Bausch & Lomb | imiquimod | Teva | Used topically to treat clinically typical visible or palpable, actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults; the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older | 7/30/2020 |
| Levo-T | Cediprof | levothyroxine sodium | Lannett | Used to treat an underactive thyroid gland (hypothyroidism) | 8/3/2020 |
| Canasa | Allergan | mesalamine | Camber | Used to treat a certain bowel disease (ulcerative colitis) | 8/3/2020 |
| Ciprodex | Novartis | ciprofloxacin / dexamethasone | Dr. Reddy's | Used to treat infections caused by susceptible isolates of the designated microorganisms in the specific conditions Acute Otitis Media in pediatric patients and Acute Otitis Externa |
8/11/2020 |
| Yaz | Bayer | drospirenone / ethyl estradiol | Camber | Used as a contraception to prevent pregnancy | 8/11/2020 |
| Zyflo CR | Chiesi | zileuton | Lupin | Used for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older | 8/11/2020 |
| Effexor XR | Pfizer | venlafaxine | Hetero | Used to treat major depressive disorder, anxiety and panic disorder | 8/13/2020 |
| Tecfidera | Biogen | dimethyl fumarate | Mylan | Used to treat relapsing forms of multiple sclerosis (MS) | 8/19/2020 |
| Revatio | Pfizer | sildenafil | Teva | Used to treat erectile dysfunction (impotence) in men | 8/19/2020 |
| Rapaflo | Allergan | silodosin | Hetero | Used to treat the signs and symptoms of Benign Prostatic Hyperplasia (BPH) | 8/21/2020 |
| Cuprimine | Bausch & Lomb | penicillamine 250mg capsules | Dr. Reddy's | Used to 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 | 8/27/2020 |
| Cleocin T gel | Pfizer | clindamycin | Solaris | Used topically to treat acne vulgaris in patients 12 years or older | 8/31/2020 |
| MoviPrep | Bausch & Lomb | PEG-3350 / sodium sulfate / sodium chloride / potassium / sodium ascorbate | Teva | Used to cleanse the colon as a preparation for colonoscopy in adults | 8/31/2020 |
| Concerta | Johnson & Johnson | methylphenidate | Dr. Reddy's | Used to treat Attention Deficit Hyperactivity Disorder (ADHD) | 9/3/2020 |
| Arava | Sanofi | leflunomide | Lupin | Used to treat adults with active rheumatoid arthritis (RA) | 9/2/2020 |
| Bafiertam | Banner | monomethyl fumarate | Banner | Used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease | 9/3/2020 |
| Voltaren gel | Glaxo | diclofenac | Perrigo | Used to relieve pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands | 9/8/2020 |
| Voltaren gel | Glaxo | diclofenac | Dr. Reddy's | Used to relieve pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands | 9/9/2020 |
| Bethkis | Chiesi | tobramycin | Teva | Used to manage cystic fibrosis patients with P. aeruginosa | 9/15/2020 |
| Pataday | Novartis | olopatadine | Dr. Reddy's | Used to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander | 9/17/2020 |
| Depakote ER | AbbVie | divalproex | Lupin | Used to treat manic or mixed episodes associated with bipolar disorder, with or without psychotic features; monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures; Prophylaxis of migraine headaches | 9/22/2020 |
| Tecfidera | Biogen | dimethyl fumarate | Camber | Used to treat relapsing forms of multiple sclerosis | 9/24/2020 |
| Tecfidera | Biogen | dimethyl fumarate | Cipla | Used to treat relapsing forms of multiple sclerosis | 9/25/2020 |
| Precedex | Hospira | dexmedetomidine | Dr. Reddy's | Used for sedation of non-intubated patients prior to and/or during surgical and other procedures | 9/25/2020 |
| Tecfidera | Biogen | dimethyl fumarate | Dr. Reddy's | Used to treat relapsing forms of multiple sclerosis | 9/26/2020 |
| Ferriprox | Chiesi | deferiprone | Taro | Used to treat patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate | 9/28/2020 |
| Tecfidera | Biogen | dimethyl fumarate | Teva | Used to treat relapsing forms of multiple sclerosis | 9/28/2020 |
| Tykerb | Glaxo | lapatinib | Lupin | Used to treat advanced hormone-related breast cancer that has progressed or spread after treatment with other cancer medicines | 9/30/2020 |
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