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.
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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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