Abbreviated New Drug Applications and 505(b)(2) Applications
This Generic Launches 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 |
|---|---|---|---|---|---|
| Xyrem | Jazz | sodium oxybate | Amneal | Used to treat cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy | 7/3/2023 |
| Ganirelix | Organon | ganirelix acetate | Fresenius Kabi | Used to inhibit premature surges in luteinizing hormone, or LH, a chemical in the body that triggers reproductive processes such as ovulation; used to treat women who are undergoing controlled ovarian hyperstimulation | 7/10/2023 |
| Aczone | AbbVie | dapsone | Cosette | Used for the topical treatment of acne vulgaris | 7/13/2023 |
| Cubicin | Cubist | daptomycin | Camber | Used to treat complicated skin and skin structure infections (cSSSI) in adult patients and pediatric patients (1 to 17 years of age) | 7/27/2023 |
| Symbicort | AstraZeneca | budesonide / formoterol fumarate dihydrate | Viatris | Used in certain patients to treat asthma or chronic obstructive pulmonary disease (COPD) | 7/31/2023 |
| Duexis | Horizon | ibuprophen / famotidine | Camber | Used to (1) relieve signs and symptoms of rheumatoid arthritis and osteoarthritis and (2) decrease the risk of developing upper gastrointestinal ulcers, in patients who are taking ibuprofen for those indications | 8/1/2023 |
| Sabril | Lundbeck | vigabatrin | Upsher-Smith | Used for infantile spasms in patients 1 month to 2 years of age and Refractory Complex Partial Seizures (CPS) in adults and children 2 years and older with refractory complex partial seizures (CPS) | 8/1/2023 |
| Gadavist | Bayer | gadobutrol | Fresenius Kabi | Used as a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI) | 8/8/2023 |
| Luxiq | Mylan | betamethasone | Xiromed | Used to relieve inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp | 8/2/2023 |
| Cardura | Viatris | doxazosin mesylate | Apotex | Used to treat high blood pressure (hypertension) and symptoms of an enlarged prostate (benign prostatic enlargement) | |
| Toradol | Roche | ketorolac tromethamine | Camber | Used for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting | 8/7/2023 |
| Mozobil | Genzyme | plerixafor | Fresenius Kabi | Used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma | 8/9/2023 |
| Jadenu Sprinkle | Novartis | deferasirox | Camber | Used to treat chronic iron overload (1) due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older, and (2) in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes exhibiting elevated liver and serum iron concentrations | 8/8/2023 |
| Spiriva HandiHaler | Boehringer Ingelheim | tiotropium bromide | Lupin | Used to treat chronic obstructive pulmonary disease (COPD) | 8/16/2023 |
| Pepcid | Johnson & Johnson | famotidine | Upsher-Smith | Used to treat active duodenal ulcer, active gastric ulcer, symptomatic non-erosive gastroesophageal reflux disease (GERD), and erosive esophagitis due to GERD, diagnosed by biopsy | 8/15/2023 |
| Balcoltra | Avion | levonorgestrel / ethinyl estradiol | Xiromed | Used as an oral contraceptive | 8/17/2023 |
| Apriso | Valeant | mesalamine | Upsher-Smith | Used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease) | 8/21/2023 |
| Zetia | Organon | ezetimibe | Hetero | Used to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin); reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate; reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin; reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) |
8/24/2023 |
| Alphagan | AbbVie | brimonidine tartrate | Apotex | Used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension | 9/2/2023 |
| Aubagio | Sanofi | teriflunomide | Apotex | Used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease | 9/6/2023 |
| Zyprexa | Eli Lilly | olanzapine | Camber | Used to treat acute agitation associated with schizophrenia and bipolar I mania | 9/25/2023 |
| Rozerem | Takeda | ramelteon | Ziromed | Used to treat insomnia characterized by difficulty with sleep onset | 9/29/2023 |
