Generic Drug Launches and 505b2 Applications Summer 2021

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

Second 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
Astelin	MEDA	azelastine	Aurobindo	Used for the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older and perennial allergic rhinitis in patients 6 years of age and older	4/6/2021
Kuvan	Biomarin	saproterin	Dr. Reddy's	Used to lower blood Phe levels in adults and children over one month of age with a certain type of Phenylketonuria (PKU)	4/7/2021
Urocit-K	Mission	potassium citrate	Hetero/Camber	Used for preventing certain types of kidney stones	4/8/2021
Librax	Bausch & Lomb	chlordiazepoxide / clidinium	Xiromed	Used to treat emotional distress caused by having a stomach disorder (such as an ulcer, irritable bowel syndrome, or intestinal infection)	4/9/2021
Quelicin	Hospira	succinylcholine chloride	Nexus	Used as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation	4/16/2021
Sabril	Lundbeck	vigabatrin	Hetero/Camber	Used to treat Refractory Complex Partial Seizures and Infantile Spasms	4/20/2021
Bloxiverz	Exela	neostigamine	Hetero/Camber	Used to reverse the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery	4/22/2021
Canasa	AbbVie	mesalamine	Teva	Used to treat mildly to moderately active ulcerative proctitis	4/23/2021
Absorica	Sun	isotretinoin	Teva	Used to manage of severe recalcitrant nodular acne in patients 12 years of age and older	4/29/2021
Enablex	APIL	darifenacin	Xiromed	Used to treat overactive bladder with symptoms of urge urinary incontinence, urgency and frequency	5/5/2021
Precedex	Pfizer	dexmedetomidine	Hikma	Used for sedation of non-intubated patients prior to and/or during surgical and other procedures	5/6/2021
Taxotere	Sanofi	docetaxel	Hikma	Microtubule inhibitor indicated for the treatment of breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck cancer	5/7/2021
Invanz	Merck	ertapenem	Dr. Reddy's	Used to treat adult patients and pediatric patients (3 months of age and older) with the moderate to severe infections caused by susceptible isolates of the designated microorganisms in complicated intra-abdominal infections, complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis, community acquired pneumonia, complicated urinary tract infections including pyelonephritis and acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections	5/12/2021
Thiola	Mission	tiopronin	Teva	Used, in combination with high fluid intake, alkali, and diet modification, for the prevention of cysteine (kidney) stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone	5/17/2021
Miacalcin	Mylan	calcitonin salmon	Leucadia/Custopharm	Used for the early treatment of hypercalcemic emergencies when a rapid decrease in serum calcium is required	5/17/2021
Torisel	Pfizer	temsirolimus	Fresenius Kabi	Used to treat advanced renal cell carcinoma	5/21/2021
Strattera	Eli Lilly	atamoxetine	Hetero/Camber	Used to treat attention-deficit/hyperactivity disorder (ADHD)	5/24/2021
Vigamox	Novartis	moxifloxacin	Upsher-Smith	Used to treat bacterial conjunctivitis caused by susceptible strains of the organisms	5/27/2021
Banzel	Eisai	rufinamide	Hetero/Camber	Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults	6/1/2021
Banzel	Eisai	rufinamide	Glenmark	Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults	6/1/2021
Delestrogen	Sandoz	estradiol valerate	Hikma	Used for the treatment of vasomotor symptoms associated with menopause; (ii) in the management of hormonal imbalances due to castration or primary ovarian failure; and (iii) in the treatment of androgen-dependent carcinoma of the prostate.	6/2/2021
Brovana	Sunovion	arformoterol	Lupin	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.	6/3/2021
Kaletra	AbbVie	lopinavir / ritonavir	Hetero/Camber	Used with other HIV medications to help control HIV infection	6/7/2021
Prevacid	Takeda	lansoprazole	Hetero/Camber	Used to treat high levels of stomach acid; active ulcers of the stomach and small intestine, Gastroesophageal Reflux Disease (GERD), and Zollinger-Ellison Syndrome	6/15/2021
Soolantra	Galderma	ivermectin	Teva	Used to treat inflammatory lesions of rosacea.	6/16/2021
Truvada	Gilead	emtricitabine / tenofovir	Apotex	Used, in combination with other antiretroviral agents for the treatment of HIV-1 infection	6/18/2021
Vascepa	Amarin	icosapent	Dr. Reddy's	Used as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia	6/22/2021
Perforomist	Mylan	formoterol	Teva	Used with a nebulizer to control the symptoms of COPD in adults, including those with chronic bronchitis and/or emphysema, the two main types of the disease	6/22/2021
Banzel	Eisai	rufinamide	Hikma	Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults	6/24/2021
Truvada	Gilead	emtricitabine / tenofovir	Lupin	Used, in combination with other antiretroviral agents for the treatment of HIV-1 infection	6/25/2021
Absorica	Sun	isotretinoin	Upsher-Smith/Sawai	Used to manage severe recalcitrant nodular acne in patients 12 years of age and older	6/25/2021