Generic Drug Launches and 505b2 Applications

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
Astepro Allergy	Bayer	azelastine	Amneal	Used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older	7/18/2022
Astepro Allergy	Bayer	azelastine	Apotex	Used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older	7/18/2022
Astepro Allergy	Bayer	azelastine	Aurobindo	Used for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older	7/18/2022
Allegra D 24 Hr	Sanofi	fexofenadine / pseudoephedrine	Dr. Reddy's Labs	Used to treat the symptoms of sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold (Seasonal Allergic Rhinitis with Nasal Congestion)	7/22/2022
Prilosec	AstraZeneca	ompeprazole	Apotex	Used for short-term treatment (4 to 8 weeks) of active duodenal ulcer or active benign gastric ulcer in adults	8/10/2022
Sectral	Promius	acebutolol	ANI	Used to manage hypertension in adults	8/3/2022
Clindagel	Bausch	clindamycin	Amneal	Used for topical application in the treatment of acne vulgaris	8/11/2022
Vasostrict	Endo / Par	vasopressin	Amneal	Used to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines	8/11/2022
Vasostrict	Endo / Par	vasopressin	Aurobindo	Used to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines	8/16/2022
Desyrel	Angelini	trazodone	Apotex	Used to treat major depressive disorder (MDD) in adults	8/25/2022
Ryaltirs	Hikma	olopatadine / mometasone	Hikma	Used to treat moderate to severe nasal symptoms associated with allergic rhinitis	8/30/2022
Revlimid	Celgene	lenalidomide	Lotus	Used to treat adult patients with multiple myeloma (MM)	9/5/2022
Revlimid	Celgene	lenalidomide	Dr. Reddy's	Used to treat adult patients with multiple myeloma (MM)	9/7/2022
Suprep Bowel Prep Kit	Braintree	sodium sulfate / potassium sulfate / magnesium sulfate	Lupin	Used to cleanse the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older	9/9/2022
Protopic	Astellas	tacrolimus	Teva	Used for short term and intermittent long term therapy in the treatment of patients with moderate to severe atopic dermatitis	9/9/2022
Tazorac	AbbVie	tazarotene	Cosette	Used for topical treatment of stable plaque psoriasis	9/15/2022
Faslodex	AstraZeneca	fulvestrant	Hikma	Used to treat HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy	9/20/2022
Velcade	Sanofi	bortezomib	Hikma	Used to treat patients with mantle cell lymphoma	9/20/2022
Revlimid	Celgene	lenalidomide	Zydus	Used to treat adult patients with multiple myeloma (MM)	9/20/2022
Samsca	Otsuka	tolvaptan	Camber / Hetero	Used to treat clinically significant hypervolemic and euvolemic hyponatremia	9/23/2022
Vesicare	Astellas	solifenacin	Camber / Hetero	Used to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency	9/28/2022
Revatio	Mylan	sildenafil	Lupin	Used to treat pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening	9/29/2022