| 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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