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FDA Listing of Authorized Generics As of July 1, 2021

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FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc. 2 ACCOLATE Tablets 10 mg AstraZeneca 11/19/2010 Pharmaceuticals 3 ACCOLATE Tablets 20 mg AstraZeneca 11/19/2010 Pharmaceuticals 4 ACCUNEB Solution 0.63 mg/3 mL Mylan Specialty 02/2012 L.P. 5 ACCUNEB Solution 1.25 mg/3 mL Mylan Specialty 02/2012 L.P. NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 6 ACCURETIC Tablets 10 mg/12.5 mg Pfizer 02/06/2006 Pharmaceuticals Ltd. 7 ACCURETIC Tablets 20 mg/12.5 mg Pfizer 02/06/2006 Pharmaceuticals Ltd. 8 ACCURETIC Tablets 20 mg/25 mg Pfizer 02/06/2006 Pharmaceuticals Ltd. 9 ACEPHEN Suppositories 120 mg G & W Laboratories, Prior to 1/1/1999 Inc. 10 ACETADOTE Injection 6 g/30 mL (200 mg/mL) Cumberland 1/7/2013 Pharmaceuticals, Inc. 11 ACTICLATE Tablets 150 mg Almirall, LLC 02/2018 12 ACTICLATE Tablets 75 mg Almirall, LLC 02/2018 13 ACTIGALL Capsules 300 mg Allergan Sales, LLC 08/13/2003 14 ACTIQ Lozenge 600 mcg Cephalon, Inc. 09/26/2006 15 ACTIQ Lozenge 800 mcg Cephalon, Inc. 09/26/2006 16 ACTIQ Lozenge 400 mcg Cephalon, Inc. 09/26/2006 17 ACTIQ Lozenge 1200 mcg Cephalon, Inc. 09/26/2006 18 ACTIQ Lozenge 1600 mcg Cephalon, Inc. 09/26/2006 19 ACTIQ Lozenge 200 mcg Cephalon, Inc. 09/26/2006 20 ACTIVELLA Tablets 1 mg / 0.5 mg Amneal 01/2019 Pharmaceuticals LLC 21 ACTONEL Tablets 150 mg Warner Chilcott 06/2014 Company LLC NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 22 ACTOS Tablets 15 mg Takeda 08/17/2012 Pharmaceuticals USA 23 ACTOS Tablets 30 mg Takeda 08/17/2012 Pharmaceuticals USA 24 ACTOS Tablets 45 mg Takeda 08/17/2012 Pharmaceuticals USA 25 ACULAR LS Ophthalmic 0.4% Allergan, Inc. 11/11/2013 Solution 26 ACZONE Gel 7.5% Almirall, LLC 01/2020 27 ADDERALL XR Extended- 30 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 28 ADDERALL XR Extended- 25 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 29 ADDERALL XR Extended- 15 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 30 ADDERALL XR Extended- 30 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 31 ADDERALL XR Extended- 20 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 32 ADDERALL XR Extended- 5 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 33 ADDERALL XR Extended- 10 mg Takeda 10/2016 - 10/2017 release Pharmaceuticals Capsules USA Inc. 34 ADDERALL XR Extended- 10 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 35 ADDERALL XR Extended- 20 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 36 ADDERALL XR Extended- 15 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 37 ADDERALL XR Extended- 25 mg Takeda 04/02/2009 release Pharmaceuticals Capsules USA Inc. 38 ADRENACLICK Injection 0.3 mg Impax Laboratories, 04/01/2010 LLC 39 ADRENACLICK Injection 0.15 mg Impax Laboratories, 04/01/2010 LLC 40 ADVAIR DISKUS Inhalation 500/50 mcg GlaxoSmithKline 02/2019 Powder Intellectual Prop. Ltd. England 41 ADVAIR DISKUS Inhalation 100/50 mcg GlaxoSmithKline 02/2019 Powder Intellectual Prop. Ltd. England NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 42 ADVAIR DISKUS Inhalation 250/50 mcg GlaxoSmithKline 02/2019 Powder Intellectual Prop. Ltd. England 43 AGGRENOX Capsules 25 mg and 200 mg Boehringer 08/2018 Ingelheim Pharmaceuticals, Inc 44 AIRDUO Inhalation 55 mcg / 14 mcg Teva Branded 04/2017 RESPICLICK Powder Pharmaceutical Products R&D Inc. 45 AIRDUO Inhalation 232 mcg / 14 mcg Teva Branded 04/2017 RESPICLICK Powder Pharmaceutical Products R&D Inc. 46 AIRDUO Inhalation 113 mcg / 14 mcg Teva Branded 04/2017 RESPICLICK Powder Pharmaceutical Products R&D Inc. 47 ALBENZA Tablets 200 mg Impax Laboratories, 09/2018 LLC 48 ALDACTAZIDE Tablets 25 mg/25 mg Pfizer Inc. 10/06/2003 49 ALDACTONE Tablets 25 mg Pfizer Inc. 6/18/2003 50 ALDACTONE Tablets 50 mg Pfizer Inc. 6/18/2003 51 ALLEGRA Tablets 30 mg Sanofi Aventis US 02/2005 - 02/2006 LLC 52 ALLEGRA Tablets 60 mg Sanofi Aventis US 02/2005 - 02/2006 LLC 53 ALLEGRA Tablets 180 mg Sanofi Aventis US 02/2005 - 02/2006 LLC 54 ALLEGRA-D 12 Extended- 60 mg/120 mg Sanofi Aventis US 12/2004 - 12/2005 HOUR release Tablets LLC NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 55 AMARYL Tablets 1 mg Sanofi Aventis US 11/2004 - 11/2005 LLC 56 AMARYL Tablets 2 mg Sanofi Aventis US 11/2004 - 11/2005 LLC 57 AMARYL Tablets 4 mg Sanofi Aventis US 11/2004 - 11/2005 LLC 58 AMBIEN Tablets 5 mg Sanofi Aventis US 12/2006 - 12/2007 LLC 59 AMBIEN Tablets 10 mg Sanofi Aventis US 12/2006 - 12/2007 LLC 60 AMBIEN CR Extended- 6.25 mg Sanofi Aventis U.S. 10/2010 release Tablets LLC 61 AMBIEN CR Extended- 12.5 mg Sanofi Aventis U.S. 12/2010 release Tablets LLC 62 AMICAR Tablets 1000 mg Clover 06/01/2012 Pharmaceuticals Corporation 63 AMMONUL Injection 10% / 10% Bausch Health US, 03/2017 LLC 64 AMPYRA Tablets 10 mg Acorda Therapeutics, 09/2018 Inc. 65 AMRIX Capsules 30 mg Cephalon, Inc. 03/2019 66 AMRIX Capsules 15 mg Cephalon, Inc. 03/2019 67 AMRIX Capsules 30 mg Cephalon, Inc. 03/2019 68 AMRIX Capsutls 15 mg Cephalon, Inc. 03/2019 69 ANAFRANIL Capsules 50 mg Mallinckrodt 07/2015 70 ANAFRANIL Capsules 25 mg Mallinckrodt 07/2015 NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 71 ANAFRANIL Capsules 75 mg Mallinckrodt 07/2015 72 ANAPROX DS Tablets 550 mg Atnahs Pharma US 10/2018 Limited 73 ANCOBAN Capsules 250 mg Bausch Health US, 07/2017 LLC 74 ANCOBAN Capsules 500 mg Bausch Health US, 01/17/2012 LLC 75 ANDROGEL Gel 1.62% AbbVie Inc. 11/2019 76 ANGIOMAX Powder, for 250 mg Sandoz Inc. 10/2015 injection solution, lyophilized 77 ANGIOMAX Powder, for 250 mg Sandoz Inc. 02/2017 injection solution, lyophilized 78 ANTARA Capsules 43 mg Lupin, Inc. 02/22/2013 79 ANTARA Capsules 130 mg Lupin, Inc. 02/22/2013 80 APADAZ Tablets 8.16 mg / 325 mg KVK-Tech, Inc. 06/2019 81 APRISO Extended- 375 mg Salix 07/2018 release Pharmaceuticals, Capsules Inc. 82 APTENSIO XR Extended- 15 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 83 APTENSIO XR Extended- 50 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 84 APTENSIO XR Extended- 20 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 85 APTENSIO XR Extended- 30 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 86 APTENSIO XR Extended- 40 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 87 APTENSIO XR Extended- 60 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 88 APTENSIO XR Extended- 10 mg Rhodes 04/2020 release Pharmaceuticals Capsules L.P. 89 ARAVA Tablets 10 mg Sanofi Aventis US 09/07/2015 LLC 90 ARAVA Tablets 20 mg Sanofi Aventis US 09/07/2015 LLC 91 ARICEPT Film coated 5 mg Eisai, Inc. 11/25/2009 - 11/24/2010 tablets 92 ARICEPT Film coated 10 mg Eisai, Inc. 11/25/2009 - 11/24/2010 tablets 93 ARICEPT ODT Orally 10 mg Eisai, Inc. 10/18/2009 - 11/24/2010 disintegrating tablets NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 94 ARICEPT ODT Orally 5 mg Eisai, Inc. 10/18/2009 - 11/24/2010 distinegrating tablets 95 ARIXTRA Injection 5 mg / 0.4 mL Mylan Ireland 12/2014 - 12/2015 Limited 96 ARIXTRA Injection 10 mg / 0.8 mL Mylan Ireland 12/2014 - 12/2015 Limited 97 ARIXTRA Injection 2.5 mg / 0.5 mL Mylan Ireland 12/2014 - 12/2015 Limited 98 ARIXTRA Injection 7.5 mg / 0.6 mL Mylan Ireland 12/2014 - 12/2015 Limited 99 AROMASIN Tablets 25 mg Pharmacia & Upjohn 11/02/2010 LLC 100 ARTHROTEC Tablets 75 mg/200 mcg Pfizer Inc.
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    SPECIALTY & GENERIC PHARMA Q1 2021 Report Market Commentary – Debt Capital Markets Debt Markets ▪ 2020 saw increased amounts of debt used in buyouts across the board, resulting in the highest debt / EBITDA Median US Buyout Multiples levels since 2014 − The increased use of debt was driven by 2H20 back- end loaded lending activity (primarily 4Q20) as 16.0x 12.7x 14.1x 12.2x 12.0x 11.6x 11.5x certainty around the U.S. election and vaccination 11.1x 10.0x 9.8x 12.0x 9.7x expectations increased 9.4x 8.6x 8.3x 8.2x 7.5x 7.8x 5.2x 6.7x 5.7x 5.6x ▪ 8.0x 5.9x As the effects of COVID now begin to diminish, debt 5.4x 4.4x 4.1x 3.7x 4.6x 4.3x 3.8x markets have seemingly recovered, signaling that 3.6x lenders have become increasingly comfortable with 4.0x 4.3x 6.9x 6.5x 6.3x 6.0x 5.9x 5.7x 5.7x 5.7x 5.7x 5.6x 5.3x 4.5x 4.4x macroeconomic and company-specific fundamentals 4.3x 0.0x 3.2x − With increased confidence, lenders are currently looking to provide strong leverage for high-quality assets, particularly ones that have proven their Debt/EBITDA Equity/EBITDA EV/EBITDA stability through the recent market downturn Source: PitchBook ▪ The spread on U.S. high-yield debt has returned to pre- Historical US High Yield Debt Effective Yield COVID levels − 4.22% current effective yield compared with a 12.0% 11.4% 11.38% effective yield on March 23, 2020 (peak of the pandemic) 9.0% ▪ We expect increased activity by lenders in 2021 due to: 6.0% 4.2% − Pent-up demand in M&A activity driven by the impact of COVID 3.0% − Limited Partner agreements and investor
  • The Covid–19 Pandemic and Haemoglobin Disorders

    The Covid–19 Pandemic and Haemoglobin Disorders

    THE COVID–19 PANDEMIC AND HAEMOGLOBIN DISORDERS VACCINATIONS & THERAPEUTIC DRUGS An Informational Guide from the Thalassaemia International Federation (TIF) Prepared by: Dr Androulla Eleftheriou, Executive Director, TIF Last Updated: 12 May 2020 VACCINATIONS & THERAPEUTIC DRUGS Introduction It is important to note that there are currently no FDA1 or EMA2-approved or even recommended agents for the treatment of the novel coronavirus (COVID-19), for which the World Health Organization (WHO) declared as pandemic on Wednesday 11th of March 2020. Any agent being used at this time is being administered in an experimental setting under controlled conditions. Thalassaemia International Federation (TIF) has made an effort to compile a list of studies/clinical trials for treatment and vaccines, which is by no means exhaustive as this situation is extremely labile and research in this area is dramatically intensified. New information is anticipated to be added to this guide which is prepared exclusively for TIF’s global thalassemia community. The viral genome was mapped very soon as rom early January 2020 and shared globally. In February 2020, the WHO published an overview of the potential therapeutic candidates for the treatment of COVID-19. The document outlines 76 regimens that have been proposed (as of February 17, 2020) for the treatment of patients infected with the virus. Thirty-eight of these candidates are in the preclinical state with minimal information available on their proposed mechanism, uses, doses routes, or planned trials. Sixteen of the remaining regimens contain an interferon-based product. The rest include a variety of antimicrobials, corticosteroids, convalescent plasma, and biologics. The Director-General of the WHO, Mr Tedros Adhanom, stated on the 10th of April 2020, that more than 70 countries have joined WHO’s trial to accelerate research on effective treatments and 20 Institutions and companies ‘are racing to develop a vaccine’.