Generica Launches

November, 2019

GENERICally Speaking
Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Euflexxa Ferring sodium hyaluronate Teva Used for the treatment of pain associated with osteoarthritis of the knee in patients who have failed to adequately respond to non-drug therapy and simple painkillers. 7/1/2019
Hemabate Pfizer carboprost tromethamine Dr. Reddy's Used for aborting pregnancy between the 13th and 20th weeks of gestation and in the following conditions related to second trimester abortion: (i) failure of expulsion of the fetus during the course of treatment by another method; (ii) premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; (iii) requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; and (iv) inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. Also used for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. 7/3/2019
Gleevec Novartis imatinib Lupin Used to treat certain types of leukemia (blood cancer), bone marrow disorders, and skin cancer. Also used to treat certain tumors of the stomach and digestive system. 7/9/2019
Mucinex D Reckitt-Benckiser guaifenesin / pseudoephedrine Apotex Used to treat nasal and sinus congestion. Also used to reduce chest congestion caused by the common cold, infections, or allergies. 7/9/2019
Symjepi (Epipen) Mylan epinephrine Sandoz Used for the emergency treatment of allergic reactions (Type 1) including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as idiopathic or exercise-induced anaphylaxis. 7/9/2019
Sensipar Amgen cinacalcet HCl Aurobindo Used for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKO) on
dialysis, hypercalcemia in adult patients with parathyroid carcinoma, severe hypercalcemia in adult patients with primary HPT who are unable to undergo
parathyroidectomy.
7/10/2019
Tamiflu Gilead oseltamivir Teva Used for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. Alsu used for the prophylaxis of influenza A and B in patients 1 year and older. 7/11/2019
Firazyr Shire icatibant Teva Used for the treatment of acute attacks of hereditary angioedema in adults 18 years of age and older. 7/16/2019
Allegra D 12 HR Sanofi fexofenadine / pseudoephedrine Dr. Reddy's Used for temporary relief of symptoms due to hay fever or other upper respiratory allergies that include runny nose; sneezing; itchy, watery eyes; itching of the nose or throat; for temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies; to reduce swelling of nasal passages; for temporary relief of sinus congestion and pressure; to temporarily restore freer breathing through the nose. 7/19/2019
Busulfex Otsuka busulfan Apotex Used in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. 7/19/2019
Lyrica Pfizer pregabalin Rising Used for management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, for adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury. 7/19/2019
Lyrica Pfizer pregabalin Amneal Used for management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, for adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury. 7/22/2019
Lyrica Pfizer pregabalin Teva Used for management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, for adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury. 7/22/2019
Rozerem Takeda ramelteon Dr. Reddy's Used for the treatment of insomnia characterized by difficulty with sleep onset. 7/23/2019
Rozerem Takeda ramelteon Teva Used for the treatment of insomnia characterized by difficulty with sleep onset. 7/23/2019
Rozerem Takeda ramelteon Zydus Used for the treatment of insomnia characterized by difficulty with sleep onset. 7/24/2019
Tessalon Pfizer benzonatate Hetero Used for the symptomatic relief of cough. 7/25/2019
Corgard Bayer nadolol Beximco Used  for the long-term management of patients with angina pectoris; for the treatment of hypertension, to lower blood pressure. 7/30/2019
Lyrica Pfizer pregabalin Dr. Reddy's Used for management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, for adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury. 7/30/2019
Epivir Gilead lamivudine Apotex Used  in combination with other antiretroviral agents for the treatment of HIV-1 infection. 8/6/2019
Lipitor Pfizer atorvastatin Apotex Used to reduce elevated total cholesterol (total-C), LDL cholesterol (LDL-C), apolipoprotein B (apo B), and triglyceride levels, and to increase HDL cholesterol in patients with primary hypercholesterolemia; to reduce total-C, LDL-C, and apo B levels in pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia with LDL-C ≥190 mg/dL, LDL-C ≥160 mg/dL with positive family history of premature cardiovascular disease (CVD), to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients without a history of coronary heart disease (CHD) but who have multiple CHD risk factors; to reduce the risk of MI, stroke, revascularization procedures, and angina in patients with a history of CHD. 8/6/2019
Zanaflex Acorda tizanidine Apotex Used for the management of spasticity. 8/6/2019
Doryx Mayne doxycycline Teva Used in the treatment of infections caused by bacteria and certain parasites. It is used to treat bacterial pneumonia, acne, chlamydia infections, early Lyme disease, cholera, and syphilis. It is also used to prevent malaria and in combination with quinine, to treat malaria. 8/15/2019
Myfortic Novartis mycophenolic acid Teva Used for the prophylaxis of organ rejection in adult patients receiving a kidney transplant; for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. 8/19/2019
Sabril Lundbeck vigabatrin Dr. Reddy's Used as adjunctive therapy for adults and pediatric patients 10 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. 8/20/2019
Prozac Eli Lilly fluoxetine Lupin Used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (Bulimia), and a severe form of premenstrual syndrome (Premenstrual Dysphoric Disorder). 8/23/2019
Zovirax Bausch acyclovir Teva Used for the relief of symptoms associated with perennial alacrgic rhinitis vi children 6 months to 2 years of age; for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria vi adults and children 6 months of age and older. 8/30/2019
Noxafil Merck posaconazole Par Used for prophylaxis of invasive Aspergillus and Candida infections in
patients who are at high risk of developing these infections due to being severely immuno-compromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy; for treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole.
9/3/2019
Vazculep Avadel phenylephrine Fresenius Kabi Used for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. 9/3/2019
Orfadin Swedish Orphan nitisinone Par Used for the treatment of patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. 9/4/2019
Concerta Johnson & Johnson methylphenidate Hetero Used for or the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. 9/5/2019
Emend I.V. Merck fosaprepitant Apotex Used for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin; or delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 9/5/2019
Zyban Glaxo bupropion Dr. Reddy's Used for the treatment of initial episodes of herpes genitalis; the suppression of unusually frequent recurrences of herpes genitalis (6 or more episodes per year); the acute treatment of herpes zoster (shingles) and varicella (chickenpox). 9/5/2019
Vazculep Avadel phenylephrine Hikma Used for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. 9/9/2019
Emend Merck fosaprepitant Dr. Reddy's Used for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin; or delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 9/11/2019
Suprax Lupin cefixime Lupin Used to treat certain types of bacterial infections. It is most commonly used to treat gonorrhea as well as infections of the ear, sinus, bladder, throat, and lung. 9/13/2019
Prevacid 24HR capsules Takeda lansoprazole Dr. Reddy's  Used to treat and prevent stomach and intestinal ulcers, erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. 9/16/2019
Cubicin Cubist daptomycin Cipla Used for the treatment of  complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age); for Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis; for Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age). 9/17/2019
Faslodex Astra-Zeneca fulvestrant Mylan Used for treatment of estrogen receptor positive metastatic breast cancer (cancer that has spread) in postmenopausal women, with disease progression following antiestrogen therapy. 9/17/2019
Tamiflu Gilead oseltamivir Alembic Used for treating and preventing the flu. 9/23/2019
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