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 |
| Sandostatin LAR Depot | Novartis | octreotide acetate | Teva | Used to treat severe diarrhea and flushing episodes associated with metastatic carcinoid tumors, profuse watery diarrhea associated with VIP-secreting tumors, and for long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option to reduce GH and IGF-1 levels to normal. | 10/1/2024 |
| Thiola EC | Mission | tiopronin delayed-release tablets | Teva | Used together with high fluid intake, alkali, and diet to prevent kidney stones in patients with severe homozygous cystinuria (too much cystine in the urine). | 10/8/2024 |
| Abraxane | Bristol-Myers | paclitaxel | Sandoz | Used to treat patients with metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. | 10/11/2024 |
| Pred Forte | AbbVie | prednisolone acetate | Lupin | Used to treat certain eye conditions due to inflammation or injury. | 10/15/2024 |
| Bumex | Validus | bumetanide injection | Lupin | Used to treat edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. | 11/19/2024 |
| Stromectol | Merck Sharp and Dohme | ivermectin tablets | Dr. Reddy's Labs | Used to treat onchocerciasis, but may also be effective against other worm infestations (such as strongyloidiasis, ascariasis, trichuriasis and enterobiasis). Applied topically, it may be used in the treatment of head lice infestation. | 11/26/2024 |
| Travatan Z | Sandoz | travoprost opthalmic solution | Glenmark | Used to treat glaucoma and ocular hypertension. | 11/27/2024 |
| Adrenalin | Endo | epinephrine in 0.9% sodium chloride injection | Endo | Used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. | 12/2/2024 |
| DOXY 100 | Fresenius Kabi | doxycyclin for injection | Endo | Used to treat or prevent bacterial infections, including pneumonia and other respiratory tract infections. It is also used to treat certain skin, genital, intestine, and urinary system infections | 12/10/2024 |
| Vimpat | UCB | lacosamide | Glenmark | Used to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. It acts on the central nervous system (CNS) to reduce the number and severity of seizures | 12/16/2024 |
| Vyvanse | Takeda | lisdexamfetamine dimesylate | Teva | Used to to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children 6 years of age and older. | 12/17/2024 |
| Epinephrine | BPI Labs | epinephrine injection | Fresenius Kabi | Used for the emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. | 12/17/2024 |
| Tykerb | Novartis | lapatinib tablets | Teva | Used for the emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substance | 12/19/2024 |
