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 |
| Abraxane | Bristol-Myers Squibb | paclitaxel | Teva | Used to treat various types of cancer. Indications for using paclitaxel encompass a range of cancers, including breast, ovarian, bladder, lung, prostate, melanoma, esophageal, Kaposi sarcoma, and various other solid tumors. | 7/2/2024 |
| Lunesta | Waylis | eszopiclone | Camber | Used to treat insomnia. | 6/7/2024 |
| Focinvez | Steriscience | fosaprepitant dimeglumine | Steriscience / Amneal | Used to prevent: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). | 7/9/2024 |
| Tirosint | IBSA | levothyroxine sodium | Yaral | Used to treat primary, secondary, and tertiary hypothyroidism. | 7/9/2024 |
| Thiola EC | Travere | tiopronin | Endo | Used to prevent kidney stones in patients with severe homozygous cystinuria (too much cystine in the urine). | 7/15/2024 |
| Zinc Sulfate | American Regent | zinc sulfate | Apotex | Used as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated | 8/1/2024 |
| Doxil | Baxter Healthcare | doxorubicin | Lupin | Used to treat Ovarian Cancer, Acquired Immune Deficiency Syndrome (AIDS)-related Kaposi’s Sarcoma, and Multiple Myeloma. | 8/29/2024 |
| Myrbetriq ER | Astellas | mirabegron | Lupin | Used to manage overactive bladder. | 9/4/2024 |
| Sprycel | Bristol-Myers Squibb | dasatinib | Apotex | Used to treat certain types of leukemia in both adults and children 1 year of age and older, including cases where previous treatment were not effective or tolerated. | 9/5/2024 |
| Oxtellar XR | Supernus | oxcarbazepine | Apotex | Used to treat partial-onset seizures in patients 6 years of age and older. | 9/5/2024 |
| Foscavir | Clinagen | foscarnet sodium | Hikma | Used to treat CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). | 9/23/2024 |
| Narcan | Adapt | naloxone | Teva | Used to to rapidly reverse opioid overdose. | 9/23/2024 |
