Generic Drug Launches and 505b2 Applications

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

Fourth Quarter

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
Apriso	Sunovion	mesalamine	Teva	Used to maintain remission of ulcerative colitis in patients 18 years of age and older	10/1/2021
Afinitor	Novartis	everolimus	Breckenridge	Used to treat postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole	10/1/2021
Afinitor	Novartis	everolimus	Biocon	Used to treat postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole	10/4/2021
BiCNU	Emcure	carmustine	Dr. Reddy's	Used to treat certain types of brain tumors; glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma and metastatic brain tumors	10/15/2021
Doxil	Baxter	doxorubicin	Padagis	Used to treat Ovarian Cancer, AIDS-related Kaposi’s Sarcoma and Multiple Myeloma	10/21/2021
Emerphed	Nexus	ephedrine sulfate	Par	Used to treat clinically important hypotension occurring in the setting of anesthesia	10/26/2021
Decadron	Merck	dexamethasone	Amneal	Used to treat several medical conditions, including respiratory complications associated with COVID-19	10/27/2021
Akovaz	Exela	ephedrine	Dr. Reddy's	Used to treat clinically important hypotension occurring in the setting of anesthesia	10/29/2021
Antara	Lupin	fenofibrate	Lupin	Used as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia	11/3/2021
Desferal	Novartis	deferoxamine	Apotex	Used to treat acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias	11/10/2021
Samsca	Otsuka	tolvaptan	Camber / Hetero	Used to treat hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances	11/10/2021
Targretin	Eisai	bexarotene	Teva	Used to treat cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy	11/11/2021
Zaditor	Alcon	ketotifen	Bayshore	Used to treat itchy eyes	11/15/2021
Zomig	iPR Pharmaceuticals	zolmitriptan	Padagis	Used to treat migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age)	11/16/2021
Zoloft	Pfizer	sertraline	Camber / Hetero	Used to treat major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder (SAD), and post-traumatic stress disorder (PTSD)	11/19/2021
Epiduo Forte	Galderma	adapalene / benzoyl peroxide	Teva	Used to treat acne vulgaris	12/1/2021
Brovana	Sunovion	arformoterol	Teva	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	12/6/2021
Diovan	Novartis	valsartan	Dr. Reddy's	Used to lower blood pressure, treat heart failure, or increase chances of survival after a heart attack	12/9/2021
Venlafaxine ER	Osmotica	venlafaxine	Dr. Reddy's	Used to treat Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD) with or without agoraphobia	12/9/2021
Daraprim	Vyera	pyrimethamine	Teva	Used to treat acute malaria in combination with other antimalarials only	12/15/2021
Carbaglu	Recordati	carglumic acid	Eton / ANI	Useed to treat acute and chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency	12/20/2021
Marcaine	Hospira	bupivacaine	Hikma	Used in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures	12/20/2021
Northera	Lundbeck	droxidopa	Camber / Hetero	Used to treat low blood pressure that causes severe dizziness or a light-headed feeling	12/21/2021
Narcan	Adapt	naloxone HCl	Teva	Used to treat an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond	12/22/2021
Sutent	Pfizer	sunitinib	Teva	Used to treat advanced renal cell carcinoma	12/22/2021
Narcan	Adapt	naloxone HCl	Sandoz	Used to treat an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond	12/22/2021
Butrans	Purdue	buprenorphine	Teva	Used to manage pain severe enough to require daily, around-the- clock, long-term opioid treatment and for which alternative treatment options are inadequate	12/27/2021