First Generic Drug Approvals

47 217542 Baricitinib Tablets, 1 mg, 2 mg Aurobindo Pharma USA, Inc.     Olumiant (Baricitinib) Tablets 7/22/2024 “the treatment of adult patients with moderately to severely active
rheumatoid arthritis who have had an inadequate response to
one or more TNF blockers” 46 217075 Tazarotene Cream, 0.05% Padagis Israel Pharmaceuticals Ltd     Tazorac (Tazarotene) Cream 7/15/2024 Indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs 45 216937 Nimodipine Oral Solution, 60 mg/20 mL (3 mg/ mL) Annora Pharma Private Limited     Nymalize (Nimodipine) Oral Solution 7/9/2024 For the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage 44 215647 L-Glutamine Oral Powder, 5 grams/packet Novitium Pharma LLC Endari (L-Glutamine) Oral Powder 7/8/2024 To reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older 43 212785 Indium In-111 Pentetreotide Kit for Injection, 3 mCi/mL Sun Pharmaceutical Industries, Inc.     Octreoscan (Kit for the Preparation of Indium In 111 Pentetreotide) 7/2/2024 For the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors 42 214348 Bupivacaine Liposome Injectable Suspension, 1.3% (133 mg/10 mL) and 1.3% (266 mg/20 mL) Single-Dose Vials Jiangsu Hengrui Pharmaceuticals Co., Ltd Exparel (Bupivacaine Liposome) Injectable Suspension 7/1/2024 Indicated to produce postsurgical local analgesia via infiltration in adults; regional analgesia via an interscalene brachial plexus nerve block in adults 41 204982 Phentermine and Topiramate Extended-release Capsules, 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25mg /69 mg, 15 mg/92 mg Actavis Laboratories FL, Inc. Qsymia (Phentermine and Topiramate) Extended-release Capsule 6/25/2024 Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients  40 213688 0.9% Sodium Chloride Irrigation USP, 1,000 mL, 2,000 mL, 3,000 mL Single-Dose Containers Fresenius Kabi USA, LLC Sodium Chloride Injection 0.9% 6/24/2024 For all general irrigation, washing, rinsing, dilution purposes which permit use of a sterile, non-pyrogenic electrolyte solution 39 209266 Avanafil Tablets, 50 mg, 100 mg, 200 mg Hetero Labs Limited Unit V Stendra (Avanafil) Tablets 6/14/2024 For the treatment of erectile dysfunction 38 215570 Palbociclib Tablets, 75 mg, 100 mg, 125 mg Synthon Pharmaceuticals, Inc Ibrance (Palbociclib) Tablets 6/2/2024 For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy or fulvestrant in patients with disease progression following endocrine therapy 37 217671 Halcinonide Topical Solution USP, 0.1% Encube Ethicals Private Limited Halog (Halcinonide) Topical Solution 5/29/2024 For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses 36 216421 Azelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray) Apotex Inc. Astepro (Azelastine Hydrochloride) Nasal Spray OTC 5/29/2024 Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies 35 213682 Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg Alembic Pharmaceuticals Limited Entresto (Sacubitril and Valsartan ) Tablets 5/28/2024 To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure; for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older 34 213676 Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg Laurus Labs Limited Entresto (Sacubitril and Valsartan ) Tablets 5/28/2024 To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure; for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older 33 213605 Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg Crystal Pharmaceutical (Suzhou) Co., Ltd. Entresto (Sacubitril and Valsartan) Tablets 5/28/2024 To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure; for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older 32 216343 Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% Amneal EU, Limited Timolol Maleate Ophthalmic Gel Forming Solution 5/23/2024 For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma 31 217193 Lanreotide Injection, 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL, Single-Dose InvaGen Pharmaceuticals, Inc. Somatuline Depot (Lanreotide) Injection 5/21/2024 For the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy; for the treatment of adult patients with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival; for the treatment of adults with carcinoid syndrome 30 214053 Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg and 120 mg/15 mg Apotex Inc. Descovy (Emtricitabine and Tenofovir Alafenamide) Tablets 5/17/2024 In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg; in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg; indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) 29 218354 Edaravone Injection, 30 mg/100 mL (0.3 mg/mL), Single Dose Bags Long Grove Pharmaceuticals, LLC Radicava (Edaravone) Injection 5/6/2024 For the treatment of amyotrophic lateral sclerosis 28 216199 Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Bags Gland Pharma Limited Radicava (Edaravone) Injection 5/6/2024 For the treatment of amyotrophic lateral sclerosis 27 215917 Edaravone Injection, 60 mg/100 mL (0.6 mg/mL), Single-Dose Bag Dr. Reddy’s Laboratories Limited Radicava (Edaravone) Injection 5/6/2024 For the treatment of amyotrophic lateral sclerosis 26 215508 Edaravone Injection, 30 mg/100 mL (0.3 mg/mL), Single-Dose Vials Hikma Pharmaceuticals USA, Inc.     Radicava (Edaravone) Injection 5/6/2024 For the treatment of amyotrophic lateral sclerosis 25 217791 Atropine Sulfate Ophthalmic Solution USP, 1% Somerset Therapeutics, LLC Isopto Atropine (Atropine Sulfate) Ophthalmic Solution 4/29/2024 Indicated for mydriasis; cycloplegia; penalization of the healthy eye in the treatment of amblyopia 24 216076 Midostaurin Capsules, 25 mg Teva Pharmaceuticals Development, Inc Rydapt (Midostaurin) Capsules 4/29/2024 For the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive; for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast cell leukemia 23 217813 Deflazacort Oral Suspension, 22.75 mg/mL Tris Pharma, Inc. Emflaza (Deflazacort) Oral Suspension 4/25/2024 For the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older 22 216160 Estradiol Gel, 0.06% Solaris Pharma Corporation EstroGel (Estradiol) Gel 4/22/2024 For the treatment of moderate to severe vasomotor symptoms due to menopause; for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause 21 216620 Eltrombopag for Oral Suspension, 12.5 mg and 25 mg Annora Pharma Private Limited Promacta (Eltrombopag) for Oral Suspension 4/18/2024 For the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy; for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy; for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy 20 203978 Nicardipine Hydrochloride in 0.83% Sodium Chloride Injection, 40 mg/200 mL (0.2 mg/mL), Single-Dose Containers and Nicardipine Hydrochloride in 0.86% Sodium Chloride Injection, 20 mg/200 mL (0.1 mg/mL), Single-Dose Containers InfoRLife SA Cardene (Nicardipine Hydrochloride) I.V. Premixed injection 4/17/2024 For the short-term treatment of hypertension when oral therapy is not feasible 19 218034 Doxycycline Capsules, 40 mg Dr. Reddy’s Laboratories Limited Oracea (Doxycycline) Capsules 4/8/2024 For the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients 18 216631 Doxycycline Capsules, 40 mg Lupin, Inc. Oracea (Doxycycline) Capsules 4/8/2024 For the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients 17 218047 Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-dose Vial Gland Pharma Limited Halaven (Eribulin Mesylate) Injection 4/5/2024 For the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease; unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen 16 216064 Valbenazine Capsules, 40 mg, 60 mg, 80 mg Lupin Limited Ingrezza (Valbenazine) Capsules 4/5/2024 For the treatment of adults with tardive dyskinesia 15 216795 Metronidazole Vaginal Gel, 1.3% Encube Ethicals Nuvessa (Metronidazole) Vaginal Gel 3/18/2024 For the treatment of bacterial vaginosis in females 12 years of age and older 14 218232 Finasteride and Tadalafil Capsules, 5 mg/5 mg Zydus Worldwide DMCC Entadfi (Finasteride and Tadalafil) Capsules 3/15/2024 To initiate treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks 13 216361 Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) Dr. Reddy’s Laboratories SA Lumify (Brimonidine Tartrate) Ophthalmic Solution 2/16/2024 Relieves redness of the eye due to minor eye irritations 12 216103 Nitroglycerin Ointment USP, 0.4% Dr. Reddy’s Laboratories SA Rectiv (Nitroglycerin) Ointment 2/16/2024 For the treatment of moderate to severe pain associated with chronic anal fissure 11 215574 Ospemifene Tablets, 60 mg Hetero Labs Limited Unit V Osphena (Ospemifene) Tablets 2/13/2024 For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause; for the treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause 10 217123 Deflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg Aurobindo Pharma Limited Emflaza (Deflazacort) Tablets 2/9/2024 For the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older 9 216899 Hydromorphone Hydrochloride Injection USP, 0.2 mg/mL, 0.5 mg/0.5 mL,1 mg/mL, 2 mg/mL Single-Dose Prefilled Syringes Hikma Pharmaceuticals USA, Inc. Dilaudid (Hydromorphone) Hydrochloride Injection 2/9/2024 For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate 8 209986 Cobicistat Tablets, 150 mg Mylan Laboratories Limited Tybost (Cobicistat) Tablets 2/4/2024 For the treatment of HIV-1 infection in adults and in pediatric patients 7 211239 Bromfenac Ophthalmic Solution, 0.075% Lupin Limited BromSite (Bromfenac) Ophthalmic Solution 2/2/2024 For the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery 6 205904 Dronedarone Tablets USP, 400 mg Lupin Inc. Multaq (Dronedarone) Tablets 1/31/2024 To reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF 5 214925 Pimavanserin Capsules, 34 mg MSN Laboratories Private Limited Nuplazid (Pimavanserin) Capsules 1/16/2024 For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis 4 214502 Pimavanserin Tablets, 10 mg Zydus Pharmaceuticals (USA) Inc. Nuplazid (Pimavanserin) Capsules 1/16/2024 For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis 3 214493 Pimavanserin Capsules, 34 mg Zydus Pharmaceuticals (USA) Inc. Nuplazid (Pimavanserin) Capsules 1/16/2024 For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis 2 208443 Fidaxomicin Tablets, 200 mg Actavis Laboratories FL, Inc. Dificid (Fidaxomicin) Tablets 1/16/2024 For the treatment of C. difficile-associated diarrhea 1 203640 Nilotinib Capsules, 50 mg, 150 mg, 200 mg Apotex, Inc. Tasigna (Nilotinib) Capsules 1/5/2024 For the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase; adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib; pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor therapy

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