Generic Drug Launches and 505b2 Applications of Q2 - Spring 2023

Abbreviated New Drug Applications and 505(b)(2) Applications

Second Quarter

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
Noxafil	Merck	posaconazole	Hikma	Used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection	4/3/2023
Prolixin	Apothecon	fluphenazine	Upsher Smith	Used to treat schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility	4/3/2023
Noxafil	Merck	posaconazole	Endo	Used to prevent serious fungal infections that can spread throughout the body in adults and children 2 years of age and older with a weakened ability to fight infection	4/4/2023
Bentyl	AbbVie	dicyclomine	TWi	Used to treat functional bowel disorder and irritable bowel syndrome	4/2023?
K-Tab	AbbVie	potassium chloride	TWi	Used for prophylaxis and treatment of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient	4/2023?
Combigan	AbbVie	brimonidine / timolol	Upsher Smith	Used to treat increased pressure in the eye caused by glaucoma or a condition called hypertension of the eye	4/13/2023
Depo-Testosterone	Pfizer	testoterone cypionate	Xiromed	Used as replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone	4/13/2023
Argatroban	Novartis	argatroban	Par / Endo	Used for prophylaxis or treatment of thrombosis in adult patients with heparin- induced thrombocytopenia (HIT)	4/17/2023
Lexiscan	Astellas	regadenoson	Hikma	Is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress	4/17/2023
Daliresp	AstraZeneca	roflumilast	Camber / Hetero	Used to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations	4/21/2023
Remodulin	United Therapeutics	treprostinil	Dr. Reddy's Labs	Used to treat pulmonary arterial hypertension (PAH)	4/21/2023
Zyflo CR	Chiesi	zileuton	Camber / Hetero	Is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older	4/26/2023
Delestrogen	Par	estradiol valerate	Xiromed	Used to treat moderate to severe vasomotor symptoms associated with the menopause	5/1/2023
Phernegan	Mylan	promethazine	Camber / Hetero	Used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes; also prevents motion sickness, and treats nausea and vomiting or pain after surgery; also used as a sedative or sleep aid	5/3/2023
Lexiscan	Astellas	regadenoson	Dr. Reddy's Labs	Is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress	5/5/2023
Syprine	Bausch	trientine HCl	Camber / Hetero	Used to treat patients with Wilson’s disease who are intolerant of penicillamine	5/8/2023
Cystadane	Recordati	betaine anhydrous	Eton	Used to treat homocystinuria	5/10/2023
Prezista	Johnson & Johnson	darunavir	Teva	Used to treat human immunodeficiency virus (HIV) in children age 3 or above and adults with HIV-1 infection	6/1/2023
Prezista	Johnson & Johnson	darunavir	Lupin	Used to treat human immunodeficiency virus (HIV) in children age 3 or above and adults with HIV-1 infection	6/3/2023
Mexitil	Boehringer Ingelheim	mexiletine HCl	Camber / Hetero	Used to treat documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening	6/6/2023
Iressa	AstraZeneca	gefitinib	Apotex	Used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK	6/14/2023
Treanda	Teva	bendamustine	Apotex	Used to treat chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen	6/14/2023
Vasostrict	Endo	vasopressin	Fresenius Kabi	Used to treat increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines	6/14/2023
Vimpat	UCB	lacosamide	Apotex	Used to treat partial-onset seizures in patients aged one month and older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients aged four years and older	6/14/2023
Dexilant	Takeda	dexlansoprazole	Par / Endo	Used to treat erosive esophagitis and heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)	6/15/2023
Thiamine	Fresenius Kabi	thiamine HCl	Lupin	Used to treat thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety	6/19/2023
Iressa	AstraZeneca	gefitinib	Teva	Used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK	6/21/2023
Banzel	Eisai	rufinamide	Lupin	Used for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in pediatric patients one year of age and older and adults	6/23/2023
Kinevac	Bracco Diagnostics	sincalide	Fresenius Kabi	Used to stimulate gallbladder contraction or pancreatic secretion during diagnostic tests, and accelerate fluoroscopy and x-ray examination of the intestinal tract	6/21/2023
Vancocin	ANI	vancomycin	Amneal	Used to treat serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci; also indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs	6/2023?
Noxafil	Merck	posaconazole	Endo / Par	Indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy.	6/29/2023
Midazolam	Inforlife	Midazolam in 0.9% sodium chloride	Hikma	Used for continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting	6/30/2023