Generic Drug Launches and 505b2 Applications Fall 2021

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

Third 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
Klor-Con	Upsher-Smith	potassium chloride	Hetero / Camber	used to treat patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis	7/6/2021
Ambien CR	Sanofi	zolpidem	Breckenridge	used to treat insomnia in adults	7/8/2021
Lescol XL	Novartis	fluvastatin	Lannett	used as an adjunctive therapy with changes to diet to lower cholesterol, slow the progression of heart disease, and reduce the risk of needing procedures to improve blood flow to the heart	7/12/2021
Kerydin	Anacor	tavaborole	Lupin	used topically to treat onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes	7/13/2021
Zytiga	Johnson & Johnson	abiraterone	Apotex	used to treat metastatic prostate cancer	7/14/2021
Feraheme	AMAG/Covis	ferumoxytol	Sandoz	used to treat iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had an unsatisfactory response to oral iron, or who have chronic kidney disease	7/16/2021
Revatio	Pfizer	sildenafil	Hetero / Camber	used to treat erectile dysfunction (impotence) in men	7/19/2021
Chantix	Pfizer	varenicline	Apotex	used as an aid to smoking cessation treatment	7/20/2021
Levitra	Bayer	vardenafil	Alembic	used to treat erectile dysfunction	7/30/2021
Extina	Mylan	ketoconazole	Xiromed	used topically to treat seborrheic dermatitis in immunocompetent patients 12 years of age and older	8/2/2021
Lioresal	Novartis	baclofen	Hetero / Camber	used to treat muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease	8/2/2021
Duexis	Horizon	ibuprofen / famotidine	Alkem	used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications	8/4/2021
Kloxxado	Hikma	naloxone nasal spray	Hikma	used in an emergency to treat known or suspected opioid overdose for adult and pediatric patients	8/4/2021
Taysofy	AbbVie	ethinyl estradiol / norethindrone / ferrous fumarate	Amneal	used to prevent pregnancy	8/5/2021
Isuprel	Bausch & Lomb	isoproterenol	Amring	used for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy	8/5/2021
Tegretol XR	Novartis	carbamazepine	Upsher-Smith	used as an anticonvulsant and specific analgesic for trigeminal neuralgia	8/16/2021
Lovenox	Sanofi	enoxaparin	Zydus	used for prophylaxis of deep vein thrombosis in patients undergoing abdominal, hip or knee replacement surgery	8/17/2021
Levophed	Hospira	noreinephrine bitartrate	Breckenridge	used to restore blood pressure control in certain acute hypotensive states	8/20/2021
Clindagel	Bausch & Lomb	clindamycin	Solaris	used topically to treat acne vulgaris	8/23/2021
Sodium Acetate	Pfizer	sodium acetate	Milla	used as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake	8/26/2021
Axiron	Eli Lilly	testosterone	Acrux / Dash Pharma	used for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone	8/26/2021
Northera	Lundbeck	droxidopa	Aurobindo	used to treat orthostatic dizziness, light headedness in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy	8/27/2021
CellCept	Roche	mycophenolate	Lannett	used for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immune-suppressants	8/30/2021
Librax	Bausch & Lomb	chlordiazepoxide / clidinium bromide	Dr. Reddy's	used to control emotional and somatic factors in gastrointestinal disorders. It may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis	8/31/2021
Jadenu	Novartis	deferasirox	Hetero / Camber	used to treat iron overload caused by blood transfusions in adults and children at least 2 years old; also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old	8/31/2021
Paxil O.S.	Glaxo	paroxetine	ANI / Novitium	used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic stress disorder	9/10/2021
Duexis	Horizon	ibuprofen / famotidine	Lupin	used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications	9/15/2021
Trisenox	Teva	arsenic trioxide	Amneal	used for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression	9/16/2021
Bystolic	AbbVie	nebivilol	ANI	used to treat hypertension, to lower blood pressure and may be used alone or in combination with other antihypertensive agents	9/17/2021
Bystolic	AbbVie	nebivilol	Hetero / Camber	used to treat hypertension, to lower blood pressure and may be used alone or in combination with other antihypertensive agents	9/17/2021
Chantix	Pfizer	varenicline	Par	used to aid smoking cessation treatment	9/22/2021
Taxotere	Sanofi	docetaxel	Xiromed / Insud	used to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy	9/27/2021
Northera	Lundbeck	droxidopa	Lupin	used to treat orthostatic dizziness, light headedness in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy	9/28/2021
Absorica	Sun	isotretinoin	Mayne	used to treat severe recalcitrant nodular acne	9/29/2021
Butrans	Purdue	buprenorphine	Apotex	used to manage pain severe enough to require daily, around-the- clock, long-term opioid treatment and for which alternative treatment options are inadequate	9/30/2021