Generic Drug Launches and 505b2 Applications Summer 2020

Drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications

Summer 2020

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	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Myfortic	Novartis	mycophenolic acid	Lupin	used for Prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant	4/6/2020
Evekeo	Arbor	amphetamine	Dr. Reddy's	used to treat narcolepsy, attention deficit disorder with hyperactivity as an integral part of a total treatment program and exogenous obesity as a short term adjunct in a regimen of weight reduction	4/14/2020
NitroDur	US Pharma	nitroglycerin	Dr. Reddy's	used to prevent angina pectoris due to coronary artery disease	4/14/2020
Istodax	Celgene	romidepsin	Teva	used to treat peripheral T-cell lymphoma and cutaneous T-cell lymphoma in patients that the cancer comes back or does not respond to other cancer treatment	4/16/2020
Tricor	AbbVie	fenofibrate	Dr. Reddy's	used to treat high cholesterol and triglycerides (fatty acids) in the blood	4/27/2020
Jadenu	Novartis	deferasirox	Teva	used to treat chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older	4/27/2020
Rapamune	Pfizer	sirolimus	Apotex	used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant	4/29/2020
Buprenex	Indivior	buprenorphine	Hikma	used to manage pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate	5/4/2020
DDAVPP	Ferring	desmopressin	Dr. Reddy's	used to control bleeding in people with mild hemophilia A.	5/6/2020
Riomet	Sun	metformin	Saptalis	used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus	5/13/2020
Sabril	Lundbeck	vigabatrin	Teva	used to treat refractory complex partial seizures (CPS) as an adjunctive therapy in patients 10 years of age and older who have responded inadequately to several alternative treatments	5/15/2020
Mycamine	Astellas	micafungin	Fresenius Kabi	used to treat candidemia, acute disseminated candidiasis, and certain other invasive Candida infections, as well as esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation	5/12/2020
Robinul	Hikma	glycopyrrolate	Apotex	used as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation and as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated	5/20/2020
Apriso	Bausch & Lomb	mesalamine	Lupin	used to maintain remission of ulcerative colitis in patients 18 years of age and older	5/19/2020
Bentyl	Allergan	dicyclomine HCl	Hikma	used to treat irritable bowel syndrome	5/28/2020
Coreg CR	GlaxoSmithKline	carvedilol	Apotex	used to treat high blood pressure; left ventricular dysfunction; heart failure; angina and belongs to the drug class non-cardioselective beta blockers	6/1/2020
Migranal	Bausch & Lomb	dihydroergotamine mesylate	Custopharm	used to treat a migraine or cluster headache attack	6/10/2020
Afinitor	Novartis	everolimus	Mylan	used to treat advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer; used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked; used to treat adults with a type of pancreatic cancer known as pancreatic euroendocrine tumor (PNET) that has progressed and cannot be treated with surgery; used to treat adults with a type of cancer known as neuroendocrine tumor (NET) of the stomach and intestine (gastrointestinal) or lung that has progressed and cannot be treated with surgery; used to treat adults with a kidney tumor called angiomyolipoma, seen with a genetic condition called tuberous sclerosis complex (TSC), when their kidney tumor does not require surgery right away; used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.	6/10/2020
Afinitor	Novartis	everolimus	Hikma	used to treat advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer; used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked; used to treat adults with a type of pancreatic cancer known as pancreatic euroendocrine tumor (PNET) that has progressed and cannot be treated with surgery; used to treat adults with a type of cancer known as neuroendocrine tumor (NET) of the stomach and intestine (gastrointestinal) or lung that has progressed and cannot be treated with surgery; used to treat adults with a kidney tumor called angiomyolipoma, seen with a genetic condition called tuberous sclerosis complex (TSC), when their kidney tumor does not require surgery right away; used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery.	6/11/2020
Colcrys	Takeda	colchicine	Dr. Reddy's	used to treat gout flares in adults and Familial Mediterranean fever (FMF) in adults and children 4 years or older	6/12/2020
Zytiga	J&J	abiraterone	Dr. Reddy's	used to treat men with prostate cancer that has spread to other parts of the body	6/19/2020