Drug Pipeline MONTHLY UPDATE
Critical updates in an ever changing environment
March 2020
NEW DRUG INFORMATION
™ ●● Anjeso (meloxicam IV): The U.S. Food and Drug Administration (FDA) approved Baudax Bio’s Anjeso for the treatment of moderate-to-severe pain. Anjeso has 30mg of meloxicam per mL and is health care administered as a once-daily intravenous bolus injection. Anjeso was approved based on two Phase 3 trials that evaluated postoperative pain in patients compared to placebo. Results demonstrated statistically significant reduction in the pain, based on the numeric pain rating scale (NPRS: baseline of 6.8) as the primary end point over the first 48 hours.1 Approval came after two complete response letter (CRL) denials from the FDA concerning onset and duration of the medication. Baudax Bio plans on launching Anjeso in late April or early May 2020 with a cost of $94 per treatment.2
™ ●● Twirla (ethinyl estradiol and levonorgestrel transdermal system): Agile Therapeutics’ Twirla received an FDA approval as a low dose contraceptive patch for the prevention of pregnancy. Twirla is a once weekly patch that Agile Therapeutics states should help increase patient compliance. As part of Twila’s approval, the FDA is requiring Agile Therapeutics to conduct a long-term prospective study comparing the risks for venous thromboembolism (VTE) and arterial thromboembolism (ATE) in new users of Twirla versus other combined hormonal contraceptives. The final study report for the Twirla study is scheduled to be submitted to the FDA in November 2032, with interim safety data reporting in November 2026. The FDA has requested additional post-marketing commitment from Agile Therapeutics to assess the residual drug content and strength.3 Currently, the only other transdermal patch available on the market is the generic version of Ortho Evra, Xulane®, that delivers 150mcg of a different progestin, norelgestromin, and 35mcg of ethinyl estradiol per day.4 Twirla is set to launch in fourth quarter 2020 with pricing to follow.5
™ ●● Vyepti (eptinezumab-jjmr): The FDA approved Adler BioPharmaceuticals’ Vyepti for the prevention of migraine. Vyepti is the first intravenous calcitonin gene-related peptide (CGRP) (compared to available subcutaneous CGRPs) that is used as preventive migraine treatment, which should be administered once every three months. Vyepti’s approval is based off two clinical trials, PROMISE-1 and PROMISE-2, which measured the frequency of migraines patients had compared to baseline. The clinical trials demonstrated a treatment benefit over placebo that was observed for both doses (100mg, 300mg) of Vyepti. PROMISE-1 demonstrated that Vyepti decreased migraine days by three to four days per month compared to baseline. PROMISE-2 demonstrated Vyetpti reduced migraine days by seven to eight days per month compared to baseline.6 Adler BioPharmaceuticals plans to launch Vyepti in April 2020 with wholesale acquisition cost (WAC) of $5,980 per year.7
While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. Drug Pipeline Monthly Update: March 2020 Page 2
™ ●● Nexletol (bempedoic acid): Esperion Therapeutics’ Nexletol has been approved by the FDA as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Nexletol is a first-in-class ATP citrate lyase inhibitor. In the past few years, there has been excitement over PCSK9 monoclonal antibodies for the treatment of cholesterol, however these agents are delivered subcutaneously and are very expensive. The FDA-approved Nexletol, based on Phase 3 study, demonstrated an average of 18% reduction of LDL-C when used with moderate or high intensity statins, compared with placebo.8 Esperion Therapeutics plan to launch Nexletol on March 30, 2020 with a wholesale acquisition cost (WAC) of $10 per day.9
™ ●● Nexlizet (bempedoic acid and ezetimibe): Esperion Therapeutics’ Nexlizet has been approved by the FDA as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Nexlizet was approved based on the Phase 3 Fixed Combination Drug Product lowering program, as well as safety data from the bempedoic acid tablet Phase 3 trial. Nexlizet lowered LDL-C by a mean of 38% compared to placebo when added on to maximally tolerated statins.10 Esperion Therapeutics plan to launch Nexlizet in July 2020 with a WAC of $10 per day.
™ ●● Barhemsys (amisulpride): The FDA has approved Acacia Pharma’s Barhemsys for post-operative nausea and vomiting who are symptomatic despite having received prophylactic treatment. Barhemsys is an intravenous selective dopamine antagonist that can be used as prophylaxis or treatment as a single agent or in combination. The FDA approved Barhemsys based on four Phase 3 studies of more than 3,300 people. The studies demonstrated Barhemsys 10mg dose alone was significantly more effective at reducing post-operative nausea and vomiting compared to placebo (42% vs. 29%) and Barhemsys 5mg dose in combination with another antiemetic significantly reduced nausea and vomiting compared to placebo (58% vs 47%).11 Acacia Pharma plans to launch Barhemsys in the second half of 2020 with pricing to follow.
™ ●● Nurtec ODT (rimegepant): Biohaven’s Nurtec orally disintegrating tablet (ODT) was approved by the FDA for treatment of acute migraine. Nurtec ODT is not for preventive migraine. Nurtec ODT is the only fast-dissolving formulation of the calcitonin gene-related peptide (CGRP) receptor antagonist class. Nurtec ODT, 75mg, can be taken without water and delivers pain relief within one hour, with sustained efficacy up to 48 hours.12 The FDA approved Nurtec ODT based on two Phase 3 clinical trials that demonstrated freedom from most bothersome symptoms at two hours post dose compared to placebo. Eighty-six percent of patients treated with Nurtec ODT did not require rescue medications within 24 hours post dose. In January 2020 the Institute for Clinical and Economic Review (ICER) evaluated CGRP receptor antagonist class and found Eli Lilly’s Reyvow® (lasmiditan), Biohaven’s Nurtec® (rimegepant) and Allergan’s Ubrelvy® (ubrogepant) all perform better than placebo, but evidence is not adequate to distinguish among them. For acute migraines, ICER states generic triptans would be the most effective and cost effective.13 Biohaven launched Nurtec ODT in March 2020, available in blister packs of eight tablets, with a WAC of $4,200-$4,600 annually.14 Drug Pipeline Monthly Update: March 2020 Page 3
™ ●● Durysta (bimatoprost sustained release implant): Allergan’s Durysta has been approved by the FDA for reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. Durysta is a biodegradable intracameral implant that is limited to a single implant per eye and should not be re-administered to an eye previously treated with Durysta due to possible corneal endothelial cell loss. The FDA approved Durysta based on two Phase 3 studies of Durysta verses twice daily topical timolol 0.5% drops. Durysta reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period (approximately 5-8mmHg in patients with a mean baseline IOP of 24.5mmHg) compared to competitior.15 Bimatoprost is available generically as an ophthalmic solution for the same indication as Allergan’s Durysta™ (bimatoprost sustained release implant). Launch and pricing pending.
GENERIC DRUG INFORMATION
® ● Camptosar inj (irinotecan inj)+: Areva Pharmaceuticals has launched its generic version of Pfizer’s Camptosar injection for treatment of colorectal cancer. There are no longer any regulatory exclusivities. Camptosar generated $10 million in U.S. annual sales in 2018.
® ● Metastron inj (strontium-89 chloride inj)+: Biomed has launched its generic version of GE Health Care’s Metastron injection for treatment of bone pain in patients with skeletal metastases. Annual sales for Metastron are unknown.
® ● Phenobarbital inj (phenobarbital inj): Cameron Pharmaceuticals launched its version of Hikma’s Phenobarbital injection used as an anticonvulsant. Phenobarbital injection annual sales are unknown.
® ● Vimovo (naproxen/esomeprazole DR): Dr Reddy’s launched its version of Horizon Therapeutics’ Vimovo for treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Multiple manufacturers are set to launch in 2020. Vimovo generated $578 million in U.S. annual sales in 2018.
® ● Dymista (azelastine/fluticasone nasal spray): Apotex launched its version of Mylan’s Dymista for treatment of seasonal allergic rhinitis. Apotex is eligible for 180-day exclusivity. Multiple manufacturers are set to launch their generic versions of Dymista in August 2020. Dymista generated $141 million in U.S. annual sales in 2018.
® ● Geodon (ziprasidone inj): Gland Pharma launched its version of Pfizer’s Geodon injection for the treatment of schizophrenia. There are no longer any regulatory exclusivities on Geodon. Geodon injection generated $23 million in U.S. annual sales in 2018.
® ● Dotarem (gadoterate meglumine, IV soln): GE Healthcare launched its version of Guerbet’s Dotarem as a contrast agent. There are no further exclusivities on Dotarem. Dotarem generated $123 million in U.S. annual sales in 2018.
® ● Zortress (everolimus)+: Hikma launched its version of Novartis’ Zortress for prophylaxis of organ rejection. Two other manufacturers are awaiting approval for their generic versions of Zortress. Zortress generated $146 million in U.S. annual sales in 2018.
+Specialty medication Drug Pipeline Monthly Update: March 2020 Page 4
NEW MOLECULAR ENTITY APPROVALS IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* rimegepant Nurtec ODT™ Biohaven Acute Migraine February 2020
eptinezumab-jjmr Vyepti™ Adler Migraine prevention February 2020 BioPharmaceuticals amisulpride Barhemsys® Acacia Pharma Post-operative nausea and vomiting February 2020
bempedoic acid Nexletol® Esperion High cholesterol February 2020 Therapeutics Inc lumateperone Caplyta® Intra-Cellular Schizophrenia December 2019 Therapies lemborexant Dayvigo® Eisai/Prudue Pharma Insomnia December 2019
ubrogepant Ubrelvy® Allergan Acute Migraine December 2019
cenobamate Xcopri™ SK Antiepileptic November 2019 Biopharmaceuticals asenapine Secuado™ Noven Schizophrenia October 2019 Pharmaceuticals lasmiditan Reyvow® Lilly Acute Migraine October 2019
tenapanor Ibsrela® Ardelyx IBS-C September 2019
istradefylline Nourianz™ Kyowa Kirin Parkinson’s disease ‘off’ episodes September 2019
pitolisant Wakix™ Harmony Narcolepsy August 2019
imipenem, cilastatin and Recarbrio™ Merck Complicated UTI and infections July 2019 relebactam *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline Monthly Update: March 2020 Page 5
OTHER NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* bimatoprost sustained-release Durysta™ Allergan Open-angle glaucoma or ocular February 2020 (SR) hypertension bempedoic acid/ezetimibe Nexlizet™ Esperion Therapeutics High cholesterol February 2020
semaglutide, oral tablet Rybelsus™ Novo Nordisk Diabetes February 2020
ethinyl estradiol and Twirla™ Agile Therapeutics Pregnancy prevention February 2020 levonorgestrel transdermal system meloxicam IV Anieso™ Baudax Bio Pain February 2020
lactitol Pizensy™ Braintree Laboratories Chronic idiopathic constipation February 2020 Inc. empagliflozin, linagliptin and Trijardy XR™ Boehringer Ingelheim Type 2 diabetes January 2020 metformin XR and Eli Lilly fidaxomicin Dificid™ Merck Clostridium difficile-associated diarrhea January 2020 (CDAD) ferric derisomaltose Monoferric™ Pharmacosmos IV iron replacement product January 2020
tazarotene Arazlo™ Ortho Dermatologics Acne vulgaris January 2020
diazepam Valtoco™ Neurelis Seizures January 2020
levamlodipine tablets Conjupri™ Conjupro Hypertension December 2019 Biotherapeutics, Inc. cefiderocol Fetroja™ Shionogi Complicated urinary tract infections (cUTI) November 2019
rifabutin, amoxicillin and Talicia™ RedHill Helicobacter pylori November 2019 omeprazole minocycline foam 4% Amzeeq™ Foamix Acne vulgaris October 2019 Pharmaceuticals cetirizine, injectable Quzyttir™ JDP Therapeutics Acute urticaria October 2019
trifarotene cream Aklief™ Galderma Laboratories Acne October 2019
dexamethasone Hemady™ Dexcel Multiple Myeloma October 2019
baclofen Ozobax™ Metacel Muscle relaxant September 2019 Pharmaceuticals fosaprepitant Fosaprepitant™ Teva Chemotherapy-induced nausea and September 2019 vomiting glucagon injection Gvoke™ Xeris Pharmaceuticals Severe hypoglycemia in diabetes September 2019
metformin HCl for extended- Riomet ER® Sun Pharma Type 2 diabetes September 2019 release oral suspension semaglutide Rybelsus® Novo Nordisk Type 2 diabetes September 2019
ferric maltol Accrufer™ Shield Therapeutics Iron deficiency July 2019
nasal glucagon Bagsimi™ Lilly Hypoglycemia July 2019
duloxetine DR Drizalma Sprinkle™ Sun Depression, anxiety, and neuropathic pain July 2019
continued Drug Pipeline Monthly Update: March 2020 Page 6
OTHER NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS (continued) DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* amlodipine benzoate suspension Katerzia™ Silvergate Pharms Hypertension July 2019
tiopronin DR Thiola EC™ Mission Pharmacal/ Cystinuria July 2019 Retrophin budesonide Ortikos™ Sun Pharma Crohn’s disease June 2019
drospirenone Slynd™ Exeltis Pregnancy prevention June 2019
dapagliflozin, saxagliptin and Qternmet XR™ AstraZeneca Type 2 diabetes May 2019 metformin hydrochloride midazolam Nayzilam™ UCB and proximagen Seizures May 2019
halobetasol propionate and Duobrii™ Ortho Dermatologics Plaque psoriasis April 2019 tazarotene (Valeant) ivabradine solution Corlanor™ Amgen To reduce the risk of hospitalization for April 2019 worsening heart failure in pediatric patients dolutegravir and lamivudine Dovato™ Viiv Healthcare HIV April 2019
colesevelam hydrochloride Welchol™ Daiichi Sankyo, Inc High cholesterol and type 2 diabetes April 2019
*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline Monthly Update: March 2020 Page 7
PIPELINE WATCH
DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* risperidone, extended-release Rykindo™ Luye Pharma Group Schizophrenia and bipolar disorder January 2020 injection naloxone nasal spray N/A Insys Opioid overdose March 2020
ET-105 (lamotrigine) N/A Eton Pharmaceuticals Seizures March 2020
rizatriptan, oral film Rizaport™ IntelGenx Migraine March 2020
E-58425 (tramadol 44mg and N/A Esteve Pharmaceuticals Pain March 2020 celecoxib 56mg tablet) fenfluramine, ZX008 Fintepla™ Zogenix Seizures associated with Dravet March 2020 syndrome ferric pyrophosphate citrate Triferic IV™ Rockwell Medical Iron replacement March 2020
opicapone Ongentys™ Neurocrine Biosciences Parkinson’s disease April 2020
dasotraline N/A Sunovion Binge eating disorder May 2020
L-lactic acid, citric acid, and Amphora™ Evofem Pregnancy prevention May 2020 potassium bitartrate FMX103 (minocycline foam 1.5%) N/A Foamix Pharmaceuticals Severe papulopustular rosacea June 2020
metoclopramide nasal spray Gimoti™ Evoke Pharma Diabetic gastroparesis June 2020
fosfomycin for injection Contepo™ Nabriva Therapeutics PLC cUTI April 2020
RVL-1201 (oxymetazoline N/A Vertical Pharmaceuticals Acquired blepharoptosis (droopy July 2020 ophthalmic solution 0.1%) (Osmotica) eyelid) calcipotriene 0.005% and Wynzora™ MC2 Therapeutics Plaque psoriasis July 2020 betamethasone 0.064% cream cantharidin 0.7% topical solution Ycanth™ Verrica Pharmaceuticals Molluscum contagiosum July 2020
donepezil, transdermal Adlarity™ Corium Alzheimer’s dementia July 2020
veverimer N/A Tricida Metabolic acidosis in patients with August 2020 chronic kidney disease (CKD) clascoterone Winlevi™ Cassiopea SPA Acne August 2020
oliceridine Olinvo™ Trevena Pain August 2020
diazepam buccal film Libervant™ Aquestive Therapeutics Seizures September 2020
ALKS 3831 (olanzapine and N/A Alkermes Schizophrenia November 2020 samidorphan) daxibotulinumtoxinA N/A Revance Therapeutics Frown lines November 2020 Drug Pipeline Monthly Update: March 2020 Page 8
FIRST GENERIC LAUNCHES OF TOP SELLING BRAND NAME DRUGS IN THE PAST TWELVE MONTHS BRAND DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* travoprost ophth soln. Travatan Z® Alcon Novartis Glaucoma or ocular hypertension December 2019
everolimus+ Afinitor® Novartis Certain forms of cancer December 2019
etonogestrel/ ethinyl estradiol NuvaRing® Organon Pregnancy prevention December 2019
deferasirox+ Jadenu® Novartis Iron overload November 2019
fosaprepitant dimeglumine Emend® Merck Sharp & Chemotherapy-induced nausea and September 2019 Dohme vomiting posaconazole Noxafil® Merck Sharp & Fungal infections September 2019 Dohme pregabalin Lyrica® Pfizer Neuropathic pain, and seizures July 2019
erlotinib+ Tarceva® Genentech Lung cancer May 2019
loteprednol etbonate Lotemax® Bausch Health Allergic conjunctivitis May 2019
solifenacin Vesicare® Astellas Incontinence April 2019
*Date usually indicates FDA approval date. The product’s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market. + Specialty medication
OTHER FIRST GENERIC LAUNCHES IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* gadoterate meglumine Clariscan® Guerbet Contrast agent March 2020
everolimus+ Zortress® Novartis Transplant March 2020
ziprasidone inj Geodon® Pfizer Schizophrenia March 2020
azelastine/fluticasone Dymista® Mylan Specialty Seasonal allergic rhinitis March 2020
naproxen/esomeprazole DR Vimovo® Horizon Therapeutics USA Arthritis February 2020
phenobarbital inj Phenobarbital inj® Hikma Seizures February 2020
strontium-89 chloride inj Metastron inj® GE Health Care Bone pain February 2020
irinotecan inj Camptosar inj® Pfizer Colorectal cancer February 2020
moxifloxacin opth soln Moxeza® Novartis Conjunctivitis February 2020
potassium chloride ER tab K-tab® Abbvie Hypokalemia January 2020
penicillamine tab Depen Titratabs® Meda Pharmaceuticals Cystinuria hepatic encephalopathy, January 2020 Mylan Wilson’s disease amphetamine ER susp Adzenys ER Neos Therapeutics Attention deficit hyperactivity December 2019 suspension® disorder
continued Drug Pipeline Monthly Update: March 2020 Page 9
OTHER FIRST GENERIC LAUNCHES IN THE PAST TWELVE MONTHS (continued)
DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* hydrocodone bitartrate 12 hr Zohydro ER caps® Pernix Therapeutics Pain December 2019 abuse-deterrent doxepin hcl Silenor® Somaxon Pharmaceuticals Insomnia December 2019
sulconazole nitrate cream, 1% Exelderm cream® Ranbaxy Pharmaceuticals Tinea corporis, tinea pedis December 2019
sulconazole nitrate solution, 1% Exelderm soln® Ranbaxy Pharmaceuticals Tinea corporis, tinea pedis December 2019
dapsone gel, 7.5% A c z o n e 7.5% ® Allergan Acne December 2019
sucralfate suspension Carafate® Forest/Allergan Ulcers December 2019
pentamidine Nebupent® Seton Pharmaceuticals Serious lung infections December 2019
mesalamine ER Apriso® Bausch Health Ulcerative colitis December 2019
ciprofloxacin/fluocinolone otic Otovel® Arbor Pharmaceuticals Ear infections November 2019
ivermectin cream, 1% Soolantra® Galderma Rosacea October 2019
aminocaproic acid oral syrup Amicar® Clover Pharmaceuticals Hemostasis September 2019
triamterene Dyrenium® Concordia Edema September 2019
halcinonide Halog® Ranbaxy Itchy skin August 2019
ramelteon Rozerem® Takeda Insomnia August 2019
icatibant injection+ Firazyr® Shire/Takeda HAE July 2019
daptomycin injection Daptomycin® Sagent/Xelia Complicated bacterial infections July 2019
carboprost injection Hemabate® Pfizer Termination of pregnancy July 2019
febuoxostat Uloric® Takeda Hyperuricemia in patients with gout July 2019
doxylamine/pyridoxine DR Diclegis® Duchesnay Nausea and vomiting in pregnancy June 2019
naftifine gel, 1% Naftin gel® Amneal Pharmaceuticals Fungal infections June 2019
sildenafil for suspension+ Revatio® Pfizer Pulmonary arterial hypertension June 2019
mifepristone Mifeprex® Dance Laboratories Termination of pregnancy May 2019
bosentan+ Tracleer® Actelion Pharmaceuticals Pulmonary hypertension May 2019
mesalamine Delzicol® Allergan IBD May 2019
penicillamine+ Cuprimine® Bausch Health Hepatic encephalopathy &Wilson’s May 2019 disease valrubicin+ Valstar® Endo Bladder cancer April 2019
ambrisentan+ Letairis® Gilead Sciences Pulmonary arterial hypertension April 2019
aliskiren Tekturna® Noden Pharma USA Hypertension April 2019
*Date usually indicates FDA approval date. The product’s launch date is determined by the manufacturer. Generic approvals that do not come to market within three months of approval are listed and dated when they enter the market. + Specialty medication Drug Pipeline Monthly Update: March 2020 Page 10
GENERICS OF TOP SELLING BRAND DRUGS POTENTIALLY AVAILABLE SOON DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* ascorbic acid; PEG; potassium Moviprep® SalixValeant Osmotic laxative 2020 chloride; sodium ascorbate; sodium chloride; sodium sulfate tolvaptan+ Samsca® Otsuka Hypernatremia 2020
albuterol sulfate Proventil® HFA/ Merck/Teva Asthma/COPD 2020 ProAir® HFA difluprednate Durezol® Alcon/Novartis Eye inflammation 2020
exenatide Byetta® AstraZeneca Diabetes 2020
teriparatide+ Forteo® Lilly Osteoporosis 2020
topiramate Qudexy XR® Upsher-Smith Seizures 2020
ethinyl estradiol Taytulla® Allergan Pregnancy prevention 2020
varenicline Tartrate Chantix® Pfizer Smoking cessation May 2020
mometasone/formoterol fumarate Dulera® Merck & Co Asthma November 2020
vilazodone hydrochloride Viibryd® Forest Depression 2021
fluticasone propionate Flovent® GSK Respiratory 2021
nebivolol Bystolic® Allergan Hypertension 2021
dabigatran Pradaxa® Boehringer Ingelheim Anticoagulant 2021 Pharmaceuticals * Expected to market dates are predictions made by Prime based on industry information. + Specialty medication
REFERENCES
1. https://www.empr.com/home/news/anjeso-approved-for-management-of-moderate-to-severe-pain/ 2. https://www.bioworld.com/articles/433229-angle-of-ketorolac-attack-yakked-as-baudax-hails-anjeso-pesos 3. https://ir.agiletherapeutics.com/news-releases/news-release-details/fda-approves-agile-therapeutics-incs-twirlar-levonorgestrel-and 4. https://www.empr.com/home/news/fda-panel-votes-in-favor-of-contraceptive-patch-despite-concerns-over-efficacy/ 5. https://www.fool.com/investing/2020/02/19/is-agile-therapeutics-stock-a-buy-after-its-big-fd.aspx 6. https://americanheadachesociety.org/news/eptinezumab-vyepti-approved-by-fda/ 7. https://scrip.pharmaintelligence.informa.com/SC141734/Pricing-Could-Help-Lundbecks-Vyepti-In-SlowGrowing-CGRP-Market 8. https://www.globenewswire.com/news-release/2020/02/21/1988825/0/en/Esperion-Announces-FDA-Approval-of-NEXLETOL-bempedoic-acid-Tablet-an-Oral-Once-Daily-Non-Statin-LDL-Cholesterol-Lowering-Medicine.html 9. https://www.fiercepharma.com/marketing/esperion-notches-2nd-fda-approval-cholesterol-lowering-combo-nexlizet 10. https://www.globenewswire.com/news-release/2020/02/26/1991460/0/en/Esperion-Announces-FDA-Approval-of-the-NEXLIZET-bempedoic-acid-and-ezetimibe-Tablet-an-Oral-Once-Daily-Non-Statin-LDL-Cholesterol- Lowering-Medicine.html 11. https://www.globenewswire.com/news-release/2020/02/27/1991526/0/en/Acacia-Pharma-Announces-US-FDA-Approval-of-BARHEMSYS-amisulpride-for-the-Treatment-and-Prevention-of-Postoperative-Nausea-and- Vomiting-PONV.html 12. https://www.biohavenpharma.com/investors/news-events/press-releases/02-27-2020 13. https://icer-review.org/announcements/acute_migraine_evidence_report/ 14. https://www.biohavenpharma.com/investors/news-events/press-releases/03-12-2020 15. https://www.allergan.com/News/Details/2020/03/Allergan%20Receives%20FDA%20Approval%20for%20DURYSTA%20bimatoprost%20implant%20the%20First%20and%20Only%20Intracameral%20Biode
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