Generic Launches

Spring 2019

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Lidex Ointment	County Line Pharmaceuticals	Fluocinonide Ointment	Lupin	indicated for the relief of the inflammatory and pruritic manifestations of Corticosteroid-Responsive Dermatoses	3/28/2019
Ritalin	Novartis	Methylphenidate HCl ER Tablets	ANI	indicated for the treatment of ADHD in children 6 years of age and older, adolescents, and adults up to the age of 65	3/27/2019
E.E.S.	Abbott Labs	Erythromycin Ethylsuccinate for Oral Suspension	ANI	indicated in the treatment of infections caused by susceptible strains of selected diseases	3/27/2019
Cialis	Eli Lilly and Company	Tadalafil Tablets	Apotex	used to treat Erectile Dysfunction (Impotence) and symptoms of Benign Prostatic Hypertrophy (Enlarged Prostate)	3/27/2019
Cialis	Eli Lilly and Company	Tadalafil Tablets	Dr. Reddy's	used to treat Erectile Dysfunction (Impotence) and symptoms of Benign Prostatic Hypertrophy (Enlarged Prostate)	3/27/2019
Prozac	Eli Lilly and Company	Fluoxetine Tablets	Upsher-Smith	used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (Bulimia), and a severe form of premenstrual syndrome (Premenstrual Dysphoric Disorder)	3/27/2019
Cialis	Eli Lilly and Company	Tadalafil Tablets	Zydus	used to treat Erectile Dysfunction (Impotence) and symptoms of Benign Prostatic Hypertrophy (Enlarged Prostate)	3/27/2019
Remodulin	United Therapeutics Corporation	Treprostinil Injection	Sandoz	indicated for Pulmonary Arterial Hypertension (PAH)	3/25/2019
Levophed	Hospira	Norepinephrine Bitartrate Injection	Hikma	indicated for blood pressure control in certain acute hypotensive states	3/22/2019
Synthroid	AbbVie	Levothyroxine Sodium Tablets	Lupin	indicated for Hypothyroidisn and Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH)	3/22/2019
Exjade	Novartis	Deferasirox Tablets for Oral Suspension	Teva	indicated for the treatment of chronic iron overload due to blood transfusions inpatients two years of age and older	3/22/2019
Exelon Patch	Novartis	Rivastigmine Transdermal System	Amneal	used to treat mild to moderate dementia caused by Alzheimer's or Parkinson's disease	3/12/2019
Rythmol SR	GlaxoSmithKline	Propafenone HCl ER Capsules	Vitruvias and Sinotherapeutics	is used to help prevent certain types of serious (possibly fatal) irregular heartbeat (such as Paroxysmal Supraventricular is indicated for the treatment of sustained Ventricular Tachycardia that is deemed to be life-threatening	3/8/2019
Amrix	Teva	Cyclobenzaprine HCl ER Capsules	Teva	for use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful masculoskeleal conditions	3/6/2019
Humalog	Eli Lilly and Company	Insulin Lispro Injection	Eli Lilly and Company (ImClone)	used to control high blood sugar in adults and children with diabetes mellitus	3/4/2019
Tekturna	Noden Pharma DAC	Aliskiren Hemifumarate Tablets	Prasco	indicated for the treatment of Hypertension in adults and children 6 years of age and older	3/4/2019
Amrix	Teva	Cyclobenzaprine HCl ER Capsules	Apotex	is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions	3/1/2019
Lovaza	GlaxoSmithKline	Omega-3 Acid Ethyl Esters Capsules	Camber Pharmaceuticals	used to lower levels of Triglycerides and may raise "good" Cholesterol	3/1/2019
Flector Patch	IBSA Institute Biochimique SA	Diclofenac Epolamine Topical Patch	Teva	used as a pain reliver indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions	3/1/2019
Amrix	Teva	Cyclobenzaprine HCl ER Capsules	Twi	indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions	3/1/2019
Rocephin	Hoffmann La Roche	Ceftriaxone for Injection	Apotex	used to treat conditions such as lower respiratory tract infections, skin and skin structure infections, urinary tract infections, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, and Meningitis	2/28/2019
Ranexa	Gilead Sciences	Ranolazine ER Tablets	Lupin	indicated for the treatment of chronic angina	2/28/2019
Ocuflox	Allergan	Ofloxacin Ophthalmic Solution	Apotex	used to treat bacterial infections of the eye, including Conjunctivitis (pink eye) and ulcers of the cornea	2/27/2019
Solodyn	Medicis Pharmaceutical	Minocycline HCl ER Tablets	Lupin	indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older	2/26/2019
Suboxone	Indivior	Buprenorphine HCl / Naloxone HCl	Mylan	for treatment of Opioid dependence	2/22/2019
Solodyn	Medicis Pharmaceutical	Minocycline HCl ER Tablets	Teva	indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older	2/21/2019
Acanya Gel	Dow Pharmaceutical Sciences	Clindamycin Phosphate / Benzoyl Peroxide Gel	Teva	indicated for the topical treatment of acne vulgaris in patients 12 years or older	2/21/2019
Suboxone	Indivior	Buprenorphine HCl / Naloxone HCl	Alvogen	for treatment of Opioid dependence	2/20/2019
Suboxone	Indivior	Buprenorphine HCl / Naloxone HCl	Dr. Reddy's	for treatment of Opioid dependence	2/20/2019
Zarontin	Pfizer	Ethosuximide Softgel Capsules	Strides Shasun	is an anti‐epileptic medication to control brief, sudden loss of consciousness and uncontrolled jerking movements in children and adults	2/20/2019
Suboxone	Indivior	Buprenorphine HCl / Naloxone HCl	Sandoz	for treatment of Opioid dependence	2/19/2019
Onfi	Lundbeck	Clobazam Oral Suspension	Lupin	indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older	2/15/2019
Zytiga	Janssen	Abiraterone Acetate Tablets	Hikma	indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC)	2/14/2019
Detrol LA	Pharmacia & Upjohn	Tolterodine Tartrate ER Capsules	Camber Pharmaceuticals	used to treat overactive bladder	2/13/2019
Achromycin	Heritage Pharms	Tetracycline Capsules	Breckenridge	used to treat many different bacterial infections, such as Urinary Tract Infections (UTI), Acne, Gonorrhea, Chlamydia, and others	2/12/2019
Adcirca	Eli Lilly and Company	Tadalafil Tablets	Dr. Reddy's	indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability	2/12/2019
Adcirca	Eli Lilly and Company	Tadalafil Tablets	Lupin	indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability	2/12/2019
Advair Diskus	Glaxo	Fluticasone Propionate / Salmeterol Inhalation Powder	Mylan	is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (Chronic Obstructive Pulmonary Disease-COPD, which includes Chronic Bronchitis and Emphysema)	2/12/2019
Advair Diskus	Glaxo	Fluticasone Propionate / Salmeterol Inhalation Powder	Prasco	is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (Chronic Obstructive Pulmonary Disease-COPD, which includes Chronic Bronchitis and Emphysema)	2/8/2019
Adcirca	Eli Lilly and Company	Tadalafil Tablets	Cipla	indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability	2/7/2019
Adcirca	Eli Lilly and Company	Tadalafil Tablets	Camber Pharmaceuticals	indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability	2/6/2019
Sabril	Lundbeck	Vigabatrin Tablets	Teva	indicated as adjunctive therapy for adults and children (10 years of age or older) with refractory Complex Partial Seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss	2/6/2019
Norco	Warner Chilcott	Hydrocodone APAP Tablets	Camber Pharmaceuticals	used to relieve moderate to severe pain	2/5/2019
Anafranil	SpecGx	Clomipramine HCl Capsules	Lupin	treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD)	2/5/2019
Adcirca	Eli Lilly and Company	Tadalafil Tablets	Teva	indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise ability	2/5/2019
Diprivan	Fresenius Kabi	Propofol Injectable Emulsion	Dr. Reddy's	used as initiation and maintenance of Monitored Anesthesia Care (MAC) sedation; combined sedation and regional anesthesia; induction of General Anesthesia Patients greater than or equal to 3 years of age; maintenance of General Anesthesia Patients greater than or equal to 2 months of age; Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients	1/24/2019
Suprane	Baxter Healthcare	Desflurane, Liquid for Inhalation	Sandoz	is an inhalation agent indicated: for induction and/or maintenance of anesthesia in adults (1.1); for maintenance of anesthesia in pediatric patients following induction with agents other than Suprane and intubation	1/24/2019
Comtan	Novartis	Entacapone Tablets	Lannett	used in the treatment of Parkinson's Disease as an adjunct to Levodopa/Carbidopa Therapy	1/22/2019
Lovenox	Sanofi Aventis	Enoxaparin Sodium Injection	Apotex	is an anticoagulant (blood thinner) used to prevent blood clots that are sometimes called Deep Vein Thrombosis (DVT), which can lead to blood clots in the lungs	1/16/2019
Symjepi	Adamis Pharmaceuticals	Epinephrine for Injection	Sandoz	for the emergency treatment of allergic reactions (Type 1), including Anaphylaxis	1/16/2019
Trandate	County Line Pharmaceuticals	Labetalol HCL Tablets	TWi Pharmaceuticals	indicated for the treatment of Hypertension	1/16/2019
Albenza	Impax Labs	Albendazole Tablets	Camber Pharmaceuticals	used to treat infections of tapeworms or other parasites	1/14/2019
Zytiga	Janssen	Abiraterone Acetate	Amneal	is used along with prednisone to treat men with prostate cancer that has spread to other areas of the body	1/9/2019
Levitra	Baxter Healthcare	Vardenafil HCl Tablets	Teva	indicated for the treatment of Erectile Dysfunction	1/8/2019
Amgen	Sensipar	Cinacalcet HCl Tablets	Teva	indicated for secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis; also used for the treatment of Hypercalcemia in adult patients with Parathyroid Carcinoma and severe Hypercalcemia in adult patients with primary HPT who are unable to undergo Parathyroidectomy	12/27/2018