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 |
|---|---|---|---|---|---|
| Astelin | MEDA | azelastine | Aurobindo | Used for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age and older | 4/6/2021 |
| Kuvan | Biomarin | saproterin | Dr. Reddy's | Used to lower blood Phe levels in adults and children over one month of age with a certain type of Phenylketonuria (PKU) | 4/7/2021 |
| Urocit-K | Mission | potassium citrate | Hetero/Camber | Used for preventing certain types of kidney stones | 4/8/2021 |
| Librax | Bausch & Lomb | chlordiazepoxide / clidinium | Xiromed | Used to treat emotional distress caused by having a stomach disorder (such as an ulcer, irritable bowel syndrome, or intestinal infection) | 4/9/2021 |
| Quelicin | Hospira | succinylcholine chloride | Nexus | Used as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation | 4/16/2021 |
| Sabril | Lundbeck | vigabatrin | Hetero/Camber | Used to treat Refractory Complex Partial Seizures and Infantile Spasms | 4/20/2021 |
| Bloxiverz | Exela | neostigamine | Hetero/Camber | Used to reverse the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery | 4/22/2021 |
| Canasa | AbbVie | mesalamine | Teva | Used to treat mildly to moderately active ulcerative proctitis | 4/23/2021 |
| Absorica | Sun | isotretinoin | Teva | Used to manage of severe recalcitrant nodular acne in patients 12 years of age and older | 4/29/2021 |
| Enablex | APIL | darifenacin | Xiromed | Used to treat overactive bladder with symptoms of urge urinary incontinence, urgency and frequency | 5/5/2021 |
| Precedex | Pfizer | dexmedetomidine | Hikma | Used for sedation of non-intubated patients prior to and/or during surgical and other procedures | 5/6/2021 |
| Taxotere | Sanofi | docetaxel | Hikma | Microtubule inhibitor indicated for the treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck cancer | 5/7/2021 |
| Invanz | Merck | ertapenem | Dr. Reddy's | Used to treat adult patients and pediatric patients (3 months of age and older) with the moderate to severe infections caused by susceptible isolates of the designated microorganisms in complicated intra-abdominal infections, complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis, community acquired pneumonia, complicated urinary tract infections including pyelonephritis and acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections | 5/12/2021 |
| Thiola | Mission | tiopronin | Teva | Used, in combination with high fluid intake, alkali, and diet modification, for the prevention of cysteine (kidney) stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone | 5/17/2021 |
| Miacalcin | Mylan | calcitonin salmon | Leucadia/Custopharm | Used for the early treatment of hypercalcemic emergencies when a rapid decrease in serum calcium is required | 5/17/2021 |
| Torisel | Pfizer | temsirolimus | Fresenius Kabi | Used to treat advanced renal cell carcinoma | 5/21/2021 |
| Strattera | Eli Lilly | atamoxetine | Hetero/Camber | Used to treat attention-deficit/hyperactivity disorder (ADHD) | 5/24/2021 |
| Vigamox | Novartis | moxifloxacin | Upsher-Smith | Used to treat bacterial conjunctivitis caused by susceptible strains of the organisms | 5/27/2021 |
| Banzel | Eisai | rufinamide | Hetero/Camber | Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults | 6/1/2021 |
| Banzel | Eisai | rufinamide | Glenmark | Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults | 6/1/2021 |
| Delestrogen | Sandoz | estradiol valerate | Hikma | Used for the treatment of vasomotor symptoms associated with menopause; (ii) in the management of hormonal imbalances due to castration or primary ovarian failure; and (iii) in the treatment of androgen-dependent carcinoma of the prostate. | 6/2/2021 |
| Brovana | Sunovion | arformoterol | Lupin | Used for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. | 6/3/2021 |
| Kaletra | AbbVie | lopinavir / ritonavir | Hetero/Camber | Used with other HIV medications to help control HIV infection | 6/7/2021 |
| Prevacid | Takeda | lansoprazole | Hetero/Camber | Used to treat high levels of stomach acid; active ulcers of the stomach and small intestine, Gastroesophageal Reflux Disease (GERD), and Zollinger-Ellison Syndrome | 6/15/2021 |
| Soolantra | Galderma | ivermectin | Teva | Used to treat inflammatory lesions of rosacea. | 6/16/2021 |
| Truvada | Gilead | emtricitabine / tenofovir | Apotex | Used, in combination with other antiretroviral agents for the treatment of HIV-1 infection | 6/18/2021 |
| Vascepa | Amarin | icosapent | Dr. Reddy's | Used as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia | 6/22/2021 |
| Perforomist | Mylan | formoterol | Teva | Used with a nebulizer to control the symptoms of COPD in adults, including those with chronic bronchitis and/or emphysema, the two main types of the disease | 6/22/2021 |
| Banzel | Eisai | rufinamide | Hikma | Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults | 6/24/2021 |
| Truvada | Gilead | emtricitabine / tenofovir | Lupin | Used, in combination with other antiretroviral agents for the treatment of HIV-1 infection | 6/25/2021 |
| Absorica | Sun | isotretinoin | Upsher-Smith/Sawai | Used to manage severe recalcitrant nodular acne in patients 12 years of age and older | 6/25/2021 |
