New ANDA Cases

Spring 2017

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Diamox	Teva	Acetazolamide IR Tablets	Heritage Pharmaceuticals	indicated for the treatment of glaucoma, epilepsy, mountain sickness and fluid retention	1/4/2017
Emend	Merck Sharp & Dohme	Aprepitant Capsules	Sandoz	prescribed for patients 12 years of age or older, in combination with other antiemetic agents to help prevent nausea and vomiting caused by certain chemotherapy medicines and for adults to prevent nausea and vomiting after surgery	1/4/2017
MS Contin ER	Purdue Pharma	Morphine Sulfate ER Tablets	Lupin	indicated for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate	1/13/2017
Pacerone	Upsher-Smith Laboratories	Amiodarone Tablets	Mayne Pharma	indicated for life-threatening recurrent ventricular arrhythmia	1/13/2017
Ortho-Cyclen 28	Janssen	Norgestimate / Ethinyl Estradiol Tablets	Lupin	indicated for use by females of reproductive potential to prevent pregnancy	1/24/2017
Lotronex	Promethius Laboratories	Alosetron Hydrochloride Tablets	Amneal Pharmaceuticals	indicated for women with severe diarrhea-predominant irritable bowel syndrome (IBS)	1/30/2017
Integrilin	Merck	Eptifibatide Injection	Amneal Pharmaceuticals	used to prevent blood clots or heart attack in people with severe chest pain or other conditions, and in those who are undergoing a procedure called angioplasty (to open blocked arteries)	1/31/2017
Imdur	Schering	Isosorbide Mononitrate ER Tablets	Heritage Pharmaceuticals	indicated for the prevention of angina pectoris due to coronary artery disease	1/31/2017
Versed	Hoffman-La Roche	Midazolam Injection	Heritage Pharmaceuticals	used as an agent for preoperative sedation	1/31/2017
Tricor	AbbVie	Fenofibrate Tablets	Camber Pharmaceuticals	reduce cholesterol and triglycerides in the blood	2/1/2017
Bupap	ECR Pharmaceuticals	Butalbital Acetaminophen (APAP) Tablets	Mayne Pharma	indicated for treatment of tension headache (migraine)	2/16/2017
Ritalin LA	Novartis	Methylphenidate ER Capsules	Mayne Pharma	indicated for attention deficit hyperactivity disorder (ADHD)	2/21/2017
Pristiq	Pfizer	Desvenlafaxine Succinate ER Tablets	Breckenridge	indicated for treatment of major depressive disorder (MDD)	3/1/2017
Temovate	Fougera Pharmaceuticals	Clobetasol Propionate Scalp Application	Lupin	indicated for short-term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp	3/1/2017
Pristiq ER	Pfizer	Desvenlafaxine ER Tablets	Teva	indicated for treatment of major depressive disorder (MDD)	3/1/2017
Pristiq	Wyeth	Desvenlafaxine Succinate ER Tablets	Lupin	indicated for the treatment of major depressive disorder (MDD)	3/2/2017
Paxil CR	Apotex	Paroxetine ER Tablets	Lupin	treatment of major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder	3/7/2017
Women's Rogaine 5% Minoxidil Foam (OTC)	Johnson & Johnson	Store Brand Equivalent to Women's Rogaine Foam (OTC)	Perrigo	indicated to regrow hair on the top of the scalp	3/8/2017
Hydrocodone Bitartrate / Acetaminophen Tablets	Mikart	Hydrocodone Bitartrate / Acetaminophen Tablets	Lupin	indicated for the relief of moderate to moderately severe pain	3/9/2017
Pristiq	Wyeth	Desvenlafaxine Succinate ER Tablets	Hikma	indicated for the treatment of major depressive disorder (MDD)	3/10/2017
Pristiq	Pfizer	Desvenlafaxine ER Tablets	Mylan	indicated for the treatment of major depressive disorder (MDD)	3/10/2017
Aromasin	Pfizer	Exemestane Tablets	Mylan	indicated in the treatment of certain types of breast cancer in women after menopause	3/13/2017
Minastrin 24 Fe	Allergan	Ferrous Fumarate Tablets	Lupin	indicated for use by females of reproductive age to prevent pregnancy	3/16/2017
Minastrin 24 Fe	Allergan	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Tablets	Teva	indicated for use by women to prevent pregnancy	3/16/2017
TOBI	Novartis	Tobramycin Inhalation Solution	Lupin	indicated for the management of cystic fibrosis patients with P. aeruginosa	3/23/2017
Eliphos	Hawthorn Pharmaceuticals	Calcium Acetate IR Tablets	Heritage Pharmaceuticals	indicated to reduce serum phosphorus in patients with end stage renal disease	3/27/2017
Xeloda	Hoffman La Roche	Capecitabine Tablets	ACETO	indicated for the treatment of metastatic breast cancer	3/28/2017
Fusilev	Spectrum Pharmaceuticals	Levoleucovorin for Injection	Amneal Biosciences	is a foliate analog indicated for rescue after high-dose methotrexate therapy for osteosarcoma and diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent over dosage of folic acid antagonists	3/28/2017
Merrem	AstraZeneca	Meropenem Injection	Aurobindo Pharma USA	indicated as single agent therapy for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections such as appendicitis and peritonitis, and bacterial meningitis	3/28/2017
Epzicom	VIIV Healthcare	Abacavir / Lamivudine Tablets	Lupin	indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection	3/29/2017
Epizcom	VIIV Healthcare	Abacavir Sulfate / Lamivudine Tablets	Aurobindo Pharma USA	indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection	3/30/2017
Zyflo CR	Chiesi USA	Zileuton ER Tablets	ACETO	indicated for the chronic treatment of asthma	3/31/2017