Abbreviated New Drug Application

Bausch Health Responds to Norwich Pharmaceuticals Tentative FDA Approval for a 200 mg Rifaximin

Retrieved on: 
Friday, September 9, 2022
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LAVAL, QC, Sept. 9, 2022 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("the Company"), and its gastroenterology business Salix Pharmaceuticals, today responded to the U.S. Food and Drug Administration's (FDA) tentative approval of the Norwich Pharmaceuticals rifaximin 200 mg product.

Key Points: 
  • LAVAL, QC, Sept. 9, 2022 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("the Company"), and its gastroenterology business Salix Pharmaceuticals, today responded to the U.S. Food and Drug Administration's (FDA) tentative approval of the Norwich Pharmaceuticals rifaximin 200 mg product.
  • The FDA will therefore not grant full approval until the expiry of the last of the Company's Orange Book listed patents for the XIFAXAN (rifaximin) 200 mg product on July 24, 2029.
  • XIFAXAN 200 mg is indicated for travelers' diarrhea and currently contributes less than 1 percent of Salix revenues.
  • Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products.

Parexel Expands Network of Global Regulatory Experts

Retrieved on: 
Thursday, September 8, 2022
Danish, Enzyme, EMA, BLA, NDA, Division, National Clinical Assessment Service, AEMPS, Regulation, Degenerative disease, Master of Science, Food and Drug Administration, Hematology, GSK, Heart, Policy, Food, LinkedIn, CMC, Hormone, Cytokine, ANDA, Access, GLOBE, HPRA, Instagram, Committee, FDA, CHMP, Compliance, Twitter, Abbreviated New Drug Application, Efficiency, Science, Safety, Danish Medicines Agency, Drug development, Industry, Health, New Drug Application, Patient, CRO, Pharmaceutical industry, Medical device, Vaccine, EU, Parexel

Parexel has proven to be a reliable and effective regulatory partner in helping our enterprise and biotech customers address ever-evolving regulatory changes and compete on a global scale, said Paul Bridges, Executive Vice President, Regulatory & Access, Parexel.

Key Points: 
  • Parexel has proven to be a reliable and effective regulatory partner in helping our enterprise and biotech customers address ever-evolving regulatory changes and compete on a global scale, said Paul Bridges, Executive Vice President, Regulatory & Access, Parexel.
  • The new leaders join Parexels more than 1,000 seasoned experts whose combined knowledge, skill and experience in quality and compliance expertly guide customers through complex global and in-country regulations.
  • They will provide their insight and expertise on key aspects of the regulatory process, including navigating rapidly evolving landscapes related to regulatory meetings and submissions, compliance and market access.
  • Our new regulatory experts bring significant tenure with global health authorities along with a breadth of therapeutic expertise from rare disease to oncology and hematology and including complex modalities such as cell and gene therapy and monoclonal antibodies to leverage this innovation and navigate global regulatory processes to bring new therapies to patients faster.

Cipla receives USFDA approval for generic version of Revlimid® (Lenalidomide capsules)

Retrieved on: 
Wednesday, September 7, 2022
Patient, AB, Development, Chromosome, Inflammation, Transfusion-dependent anemia, Cancer, MCL, Bristol Myers Squibb, Lenalidomide, Social media, Therapy, YouTube, Celgene, NSE, US FDA, Capsule, Disease, Multiple myeloma, Urology, Chronic lymphocytic leukemia, Maintenance, MDS, Pregnancy, Myelodysplastic syndrome, Social, LinkedIn, CLL, Microdeletion syndrome, HIV, ANDA, Lymphatic system, Pinterest, Follicular lymphoma, Mantle cell lymphoma, Instagram, Movement, Company, Abbreviated New Drug Application, Twitter, Trial of the century, Dexamethasone, BSE, IMS, Bortezomib, Cardiology, CNS, Juno Therapeutics, HIV/AIDS, IMS Health, Pharmaceutical industry, Cipla, Marginal zone, IQVIA, Facebook

Cipla's Lenalidomide Capsules are the AB-rated therapeutic equivalent generic version of Bristol Myers Squibb's (Celgene) Revlimid(Lenalidomide) Capsules.

Key Points: 
  • Cipla's Lenalidomide Capsules are the AB-rated therapeutic equivalent generic version of Bristol Myers Squibb's (Celgene) Revlimid(Lenalidomide) Capsules.
  • Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings.
  • Lenalidomide Capsules should not be used to treat people with chronic lymphocytic leukemia (CLL) outside of a controlled clinical trial.
  • According to IQVIA (IMS Health), Revlimid(Lenalidomide) Capsules had US sales of approximately $ 2.58 billion for the 12-month period ending June 2022.

Calyptus Pharmaceuticals Announces Approval of Arformoterol Tartrate Inhalation Solution, EQ 0.015 mg Base/2 ml

Retrieved on: 
Wednesday, August 24, 2022
Respiratory disease, Partnership, Chinese Pharmaceutical Association, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Arformoterol, Maintenance, Chronic obstructive pulmonary disease, Food, Bronchoconstriction, ANDA, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., FDA, COPD, Abbreviated New Drug Application, Anders (singer), Patient, Pharmaceutical industry, IQVIA

PRINCETON, N.J., Aug. 24, 2022 /PRNewswire/ --Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for a generic version of Brovana (Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml) to Calyptus' partner - VistaPharm, Inc., ("VistaPharm" - a Pharmaceutical Associates, Inc company).

Key Points: 
  • PRINCETON, N.J., Aug. 24, 2022 /PRNewswire/ --Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for a generic version of Brovana (Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 ml) to Calyptus' partner - VistaPharm, Inc., ("VistaPharm" - a Pharmaceutical Associates, Inc company).
  • Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 mlis indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
  • The successful development, and approval of a generic formulation of Arformoterol Tartrate inhalation solution is a testimony to these efforts".
  • According to IQVIA, a leading healthcare data and analytics provider, U.S. annual sales for Arformoterol Tartrate inhalation solution, EQ 0.015 mg Base/2 mlfor the 12 months ended June 2022 were approximately $104 million.

VFMCRP announces U.S. Court upholds validity of Velphoro® patent

Retrieved on: 
Monday, August 22, 2022
Medical Supplies, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Orange Book, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Fresenius Medical Care, District court, Sucroferric oxyhydroxide, Chronic kidney disease, Teva, Vifor Pharma, Judgement, Blood, Dialysis, CSL, Patent, Multimedia, Nephrology, ANDA, District, Douglas v. U.S. District Court ex rel Talk America, Abbreviated New Drug Application, ASX, Intellectual property, Anders (singer), Marketing, Patient, Generic drug

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in VFMCRPs favor regarding U.S. patent no.

Key Points: 
  • Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in VFMCRPs favor regarding U.S. patent no.
  • Currently, Velphoro is protected by multiple Orange Book listed patents which expire between May 2029 and May 2035.
  • View the full release here: https://www.businesswire.com/news/home/20220821005007/en/
    A further ANDA patent infringement lawsuit against Teva based on patents no.
  • CSL Vifor welcomes the decision by the U.S. District Court to uphold the patent validity of Velphoro which highlights the innovation and strength of our intellectual property, said Florian Jehle, Chief Executive Officer of VFMCRP.

Calyptus Pharmaceuticals Announces FDA Approval of Cetrorelix Acetate for Injection, 0.25 mg/vial

Retrieved on: 
Friday, August 19, 2022
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PRINCETON, N.J., Aug. 19, 2022 /PRNewswire/ -- Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for an AP-rated generic version of Cetrotide(Cetrorelix Acetate for Injection, 0.25 mg/vial) to Calyptus' partner - Akorn Operating Company LLC ("Akorn").

Key Points: 
  • PRINCETON, N.J., Aug. 19, 2022 /PRNewswire/ -- Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for an AP-rated generic version of Cetrotide(Cetrorelix Acetate for Injection, 0.25 mg/vial) to Calyptus' partner - Akorn Operating Company LLC ("Akorn").
  • In addition, the FDA granted the Competitive Generic Therapy (CGT) designation, which makes the product eligible for 180 days of CGT market exclusivity for the 0.25 mg/vial dose.
  • Cetrorelix Acetate for Injection, 0.25 mg/vial is indicated for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian stimulation.
  • Calyptus is a pharmaceutical company based in Princeton, N.J., whosemission is to improve lives of patients by increasing access and affordability of quality medicines.

Federal Circuit Rules in Favor of Eagle Pharmaceuticals in Vasopressin Litigation

Retrieved on: 
Thursday, August 18, 2022
FDA, Regulation of tobacco by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, Kirkland & Ellis, List, United States Court of Appeals for the Federal Circuit, CNS, GLOBE, Catecholamine, Forward-looking statement, Phrase, Failure, Abbreviated New Drug Application, Private Securities Litigation Reform Act, SEC, District, European Medicines Agency, Virginia General District Court, Research, Annual report, Security (finance), Compliance, ANDA, LLP, Douglas v. U.S. District Court ex rel Talk America, Marketing, Patient, Hypotension, Company, COVID-19, Drug development, District court, Par, Sepsis, Genta (company), Blood pressure, Endo International, Vasodilatory shock, Eagle, Nasdaq, Food, Online gambling, Pharmaceutical industry

Par previously sued Eagle in 2018, alleging infringement of several of its patents and a trial was held in July 2021.

Key Points: 
  • Par previously sued Eagle in 2018, alleging infringement of several of its patents and a trial was held in July 2021.
  • The District Court held that Eagle did not infringe on any of Pars patents, and Par appealed.
  • Oral arguments were held before the Federal Circuit in July 2022.
  • Today, the Federal Circuit issued its decision rejecting Pars arguments and affirming the District Courts finding of non-infringement.

Tris Pharma Announces US District Court Upholds Validity of QuilliChew ER® Patents; Rules Teva Infringes Tris Patents

Retrieved on: 
Thursday, August 18, 2022
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The ruling prevents Teva from launching generic versions of QuilliChew ER until the expiration of Tris's patent portfolio providing exclusivity until August 2033.

Key Points: 
  • The ruling prevents Teva from launching generic versions of QuilliChew ER until the expiration of Tris's patent portfolio providing exclusivity until August 2033.
  • "The decision of the District Court not only confirms the validity and infringement of our QuilliChew ER patents, but also validates the innovative nature of our LiquiXRtechnology which we utilized to develop QuilliChew ER and our other branded ADHD medications."
  • QuilliChew ER is approved for treatment of ADHD in people 6 years and older.
  • Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking QuilliChew ER.

ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Dexamethasone Tablets USP

Retrieved on: 
Tuesday, August 16, 2022
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ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Dexamethasone Tablets USP 1.5mg, 4mg and 6mg.

Key Points: 
  • ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Dexamethasone Tablets USP 1.5mg, 4mg and 6mg.
  • ANIs Dexamethasone Tablets USP 1.5mg, 4mg and 6mg are the generic version of the Reference Listed Drug (RLD) Decadron.
  • The current annual U.S. market for Dexamethasone Tablets USP 1.5mg, 4mg and 6mg is approximately $59.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • "The FDA approval and imminent launch of Dexamethasone Tablets further demonstrates our commitment to serve patients in need by bringing limited competition products to market.

Basilea reports strong financial half-year results and progress in the implementation of new anti-infectives strategy

Retrieved on: 
Tuesday, August 16, 2022
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53 LR

Key Points: 
  • 53 LR
    Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company, announced today its results for the first half-year ended June 30, 2022.
  • David Veitch, Chief Executive Officer, stated: We have made significant progress in the implementation of our new strategy.
  • We also made good progress on the separation of our oncology assets to enable us to focus our resources exclusively on our anti-infectives business from 2023.
  • Additionally, the positive topline results from the phase 3 study with our antibiotic ceftobiprole, are an important milestone for accessing the U.S. market.