Generic Launches

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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
Balcoltra Avion levonorgestrel / ethinyl estradiol Lupin Used by females of reproductive potential to prevent pregnancy. 1/13/2025
Vitamin K1 Hospira phytonadione Glenmark Used to treat coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. 1/21/2025
Chlorpromazine Hikma chlorpromazine Piramal Used to manage and treat schizophrenia, bipolar disorder, and acute psychosis. 1/22/2025
Rapamune Pfizer sirolimus Camber Used for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. 1/29/2025
Miacalcin Mylan calcitonin salmon Fresenius Kabi Used to treat postmenopausal osteoporosis when alternative treatments are not suitable. 2/10/2025
Evoclin Mylan clindamycin Glenmark Used to treat serious infections caused by susceptible anaerobic, streptococcal, staphylococcal, and pneumococcal bacteria. 2/12/2025
Asacol HD AbbVie mesalamine Amneal Used to treat moderately active ulcerative colitis in adults. 2/19/2025
Epinephrine  BPI Labs epinephrine Glenmark Used to treat hypotension associated with septic shock and for emergency responses to allergic reactions. 2/28/2025
Acetadote Cumberland acetylcysteine Glenmark Used to treat acetaminophen (Tylenol) overdose to prevent liver damage. 3/3/2025
MiraLax Bayer HealthCare polyethylene glycol 350 Glenmark Used to treat constipation in patients 17 years of age and older. 3/10/2025
Sandostatin LAR Novartis octreotide Teva Used to treat acromegaly, diarrhea and flushing associated with carcinoid tumors, and profuse watery diarrhea from VIPomas, as well as other conditions like esophageal variceal bleeding and GI fistulas.  3/20/2025
Gleevec Novartis imatinib Apotex Used to treat different types of cancer or bone marrow conditions. 3/27/2025

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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