Abbreviated New Drug Application

ANI Pharmaceuticals Announces the FDA Approval and Launch of Fluoxetine Oral Solution USP

Retrieved on: 
Monday, November 28, 2022
Health, FDA, General Health, Research, Science, Pharmaceutical, Biotechnology, Marketing, COVID-19, Growth, Abbreviated New Drug Application, Health, Nature, Food, Risk, ANDA, RLD, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, Fluoxetine, Food and Drug Administration, Security (finance), Annual report, News, Failure, ANI, Form 10-K, FDA, USP, Pharmaceutical industry

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 Fluoxetine Oral Solution, USP 20 mg/5 mL.

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 Fluoxetine Oral Solution, USP 20 mg/5 mL.
  • ANIs Fluoxetine Oral Solution is the generic version of the Reference Listed Drug (RLD) Prozac.
  • The current annual U.S. market for Fluoxetine Oral Solution is approximately $14.6 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.

ANI Pharmaceuticals Announces the FDA Approval and Launch of Trimethoprim Tablets USP

Retrieved on: 
Wednesday, November 16, 2022
Health, FDA, Other Science, Research, Science, Pharmaceutical, Biotechnology, FDA, Marketing, Abbreviated New Drug Application, Trimethoprim, Health, Failure, News, Patient, Food, RLD, Annual report, Security (finance), Nature, Form 10-K, Food and Drug Administration, Regulation of tobacco by the U.S. Food and Drug Administration, Growth, ANDA, COVID-19, Tablet, ANI, Risk, Pharmaceutical industry

ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Trimethoprim Tablets USP, 100 mg.

Key Points: 
  • ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Trimethoprim Tablets USP, 100 mg.
    ANIs Trimethoprim Tablets are the generic version of the Reference Listed Drug (RLD) of the same established name.
  • The current annual U.S. market for Trimethoprim Tablets is approximately $16.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • "As we continue to focus on bringing niche limited-competition products to market, we are pleased to announce the FDA approval and commercialization of Trimethoprim Tablets, stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
  • ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need.

MediPharm Labs Reports Third Quarter Results

Retrieved on: 
Monday, November 14, 2022
Automation, Growth, TSX, Medicine, Dronabinol, Stock, EBITDA, Abbreviated New Drug Application, Dementia, Intention, National Institute, National Institute on Aging, Partnership, Leadership, United Kingdom, University, THC, Efficiency, FDA, Sale, Company, GMP, Research, Ontario Court of Justice, Cannabinoid, API, CFO, Patient, CBD, Agitation, Completeness, CEO, AUD, Justice, FSE, Keck School of Medicine of USC, US Foods, Food, Ageing, OTCQX, Fine chemical, Pharmaceutical industry, Renewable energy, Brazilian Health Regulatory Agency, Q2, Q3

TORONTO, Nov. 14, 2022 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) ("MediPharm", "MediPharm Labs" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, today announced its financial results for the three months ended September 30, 2022.

Key Points: 
  • TORONTO, Nov. 14, 2022 /PRNewswire/ - MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) ("MediPharm", "MediPharm Labs" or the "Company") a pharmaceutical company specialized in precision-based cannabinoids, today announced its financial results for the three months ended September 30, 2022.
  • Subsequent to the quarter, the Company completed the previously announced sale of MediPharm Labs Australia Pty Ltd for AUD$7.25M.
  • In Q3 2022 MediPharm held number 2 share nationally in this subcategory, according to Hyfire point of sale data.
  • Greg Hunter, CFO, MediPharm Labs added, "In Q3 MediPharm continued to make progress improving both revenue and adjusted EBITDA on a sequential and year over year basis as we continue our path towards profitability.

Amneal Receives FDA Approval for Leuprolide Acetate Injection

Retrieved on: 
Wednesday, November 2, 2022
Oncology, FDA, Health, Other Health, General Health, Pharmaceutical, Security (finance), Growth, Annual report, Abbreviated New Drug Application, Medication, U.S. Securities and Exchange Commission, Research, Common stock, NYSE, Risk, COVID-19, Intellectual property, Federation, SVP, Ownership, Regulation of tobacco by the U.S. Food and Drug Administration, Weather, Investment, Degenerative disease, Amneal Pharmaceuticals, Private Securities Litigation Reform Act, Company, ANDA, FDA, Food, Generic, Forward-looking statement, Central nervous system, Pharmaceutical industry, Risk management

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (Amneal or the Company) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for leuprolide acetate for injection.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (Amneal or the Company) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for leuprolide acetate for injection.
  • Harsher Singh, SVP for Amneal Biosciences, stated, We are making tremendous progress expanding our injectables business.
  • Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company.

Peripheral Neuropathy Treatment Market Report 2022: Increased Product Launches & Approval Bolstering Sector Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, September 26, 2022
Health, General Health, Adoption, Central nervous system, Government, ANDA, Peripheral nervous system, Infection, Spinal cord, Brain, University School, Abbreviated New Drug Application, Industry, Treatment, Diabetes, USFDA, Peripheral neuropathy, Region, Stabbing, Pain, US, Research, Marketing, Chemotherapy-induced peripheral neuropathy, CIPN, Injury, Indiana University School of Medicine, CAGR, Pharmaceutical industry, Pregabalin, Duloxetine

The "Peripheral Neuropathy Treatment Market, by Indication, by Treatment and Non-Pharmacological Therapies, by End-user, and by Region - Size, Share, Outlook, and Opportunity Analysis, 2022 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Peripheral Neuropathy Treatment Market, by Indication, by Treatment and Non-Pharmacological Therapies, by End-user, and by Region - Size, Share, Outlook, and Opportunity Analysis, 2022 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • Peripheral neuropathy can result from traumatic injuries, infections, metabolic problems, inherited causes, and exposure to toxins.
  • Key players operating in the global peripheral neuropathy treatment market are focusing on adoption growth strategies such as product launch, and approval which are expected to drive the market growth during the forecast period.
  • Global Peripheral Neuropathy Treatment Market, By Indication :

Aptar Expands Pharmaceutical Services; Announces Exclusive Collaboration Between Aptar Pharma and Fluidda

Retrieved on: 
Thursday, September 22, 2022
Software, Research, Pharmaceutical, Data Management, Technology, Medical Devices, Packaging, Clinical Trials, Science, Biotechnology, FDA, Health, Manufacturing, Securities Exchange Act of 1934, HRCT, Bureau of Oceans and International Environmental and Scientific Affairs, ANDA, Chronic obstructive pulmonary disease, U.S. FDA, Computational fluid dynamics, NYSE, FDA, Drug Quality and Security Act, Beauty, ATR, Food and Drug Administration, PBPK, Asthma, Abbreviated New Drug Application, Securities Act of 1933, Forward-looking statement, U.S. Securities and Exchange Commission, Program, Patient, Analysis, CEO, Technology, Financial condition report, Result, Diagnosis, Food, Form, Security (finance), COPD, Multimedia, FRI, Functional, CFD, GWP, Pharmaceutical industry, Generic drug, Medical imaging, Fine chemical, Science, Analytic, AptarGroup

Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products (OINDPs), today announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging.

Key Points: 
  • Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products (OINDPs), today announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging.
  • A company would have to spend several years to achieve the current combined expertise and experience of Nanopharm and Fluidda.
  • The collaboration between Nanopharm and Fluidda has the potential to revolutionize this arduous regulatory pathway, stated Dr. Jag Shur, Vice President, Science & Technology at Nanopharm.
  • Guillaume Brouet, Vice President, Analytical, Regulatory and Scientific Affairs at Aptar Pharma, commented, Aptar Pharma is delighted to collaborate with Fluidda on this important development, which reinforces our mission to help customers derisk and accelerate their drug product development programs.

Cosette Pharmaceuticals Announces the Approval and Launch of First Generic Versions of TAZORAC® (tazarotene) gel, 0.05% and 0.1%, with 180 days Competitive Generic Therapy (CGT) exclusivity

Retrieved on: 
Tuesday, September 20, 2022
FDA, Health, Other Health, Clinical Trials, General Health, Pharmaceutical, ANDA, Abbreviated New Drug Application, FDA, Food, CGT, Regulation of tobacco by the U.S. Food and Drug Administration, Joint Medical Service (Germany), Pediatrics, CEO, Medication, Cardiology, Suppository, Multimedia, Avista Capital Partners, Generic drug

Cosette Pharmaceuticals, Inc. ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for the first generic versions of TAZORAC (tazarotene) gel, 0.05% and 0.1%, with 180 days Competitive Generic Therapy (CGT) exclusivity.

Key Points: 
  • Cosette Pharmaceuticals, Inc. ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for the first generic versions of TAZORAC (tazarotene) gel, 0.05% and 0.1%, with 180 days Competitive Generic Therapy (CGT) exclusivity.
  • Cosette has already commenced commercial shipments, triggering the 180 days exclusivity.
  • Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations.
  • Cosette has a fast-growing portfolio of branded pharmaceuticals, consisting of products in cardiology, womens health and pediatrics.

Newron provides H1 2022 results and updates on R&D and business activities

Retrieved on: 
Thursday, September 15, 2022
Health, Genetics, General Health, Research, Science, Pharmaceutical, Biotechnology, Safety, Abbreviated New Drug Application, Tablet, Chief information officer, Social Security Government Pension Offset, ESG, Schizophrenia, Director, FDA, Food, Phase, Company, Partnership, Psychosis, Patient, XETRA, Senior management, Orange Book, QI, Levodopa-induced dyskinesia, Annual report, Medication, Congress, Evenamide, Positive, Â, TRS, CINP, US Foods, PANSS, Paragraph, Board, LOF, PD, Peripheral nervous system, Social, Pharmaceutical industry, Cryptocurrency, Lithium, Management, New chemical entity, Operation, Biophysical environment, Newron Cup

We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.

Key Points: 
  • We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.
  • In June 2022, Newron presented key scientific data of evenamide at the 33rd Collegium Internationale Neuro-Psychopharmacologicum (CINP) Hybrid World Congress of Neuropsychopharmacology, in Taipei, Taiwan.
  • Newron sees significant progress in the enrolment of patients for study 014 and expects to complete the process by the end of 2022, with results from the study due in QI/2023.
  • Filippo joined Newron in November 2016 as IT Director and became Director of Operations in January 2022.

DGAP-News: Newron provides H1 2022 results and updates on R&D and business activities

Retrieved on: 
Thursday, September 15, 2022
Safety, Abbreviated New Drug Application, Tablet, Chief information officer, Social Security Government Pension Offset, ESG, Schizophrenia, Director, FDA, Food, Phase, Company, Partnership, Psychosis, Patient, XETRA, Senior management, Orange Book, QI, Levodopa-induced dyskinesia, Annual report, Congress, CET, Evenamide, Positive, Â, TRS, CINP, US Foods, PANSS, Paragraph, Board, LOF, PD, Peripheral nervous system, Social, Cryptocurrency, Pharmaceutical industry, Lithium, Management, New chemical entity, Operation, Biophysical environment, Newron Cup

We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.

Key Points: 
  • We also strengthened our senior leadership team and furthered our commitments to ESG standards, principles and outcomes.
  • In June 2022, Newron presented key scientific data of evenamide at the 33rd Collegium Internationale Neuro-Psychopharmacologicum (CINP) Hybrid World Congress of Neuropsychopharmacology, in Taipei, Taiwan.
  • Newron sees significant progress in the enrolment of patients for study 014 and expects to complete the process by the end of 2022, with results from the study due in QI/2023.
  • Filippo joined Newron in November 2016 as IT Director and became Director of Operations in January 2022.

Global FLT3 Inhibitors Market Research Report 2022: Focus on Commercialized Therapy & Potential Pipeline Products - ResearchAndMarkets.com

Retrieved on: 
Friday, September 9, 2022
General Health, Pharmaceutical, Health, Investigational New Drug, Fibroblast growth factor receptor 1, NDA, Allar, Jerusalem, Cancer, Research, Abbreviated New Drug Application, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, RCC, Therapy, IND, Benchmarking, AML, Incidence, New Drug Application, Novartis, Food, Renal cell carcinoma, Diagnosis, Acute myeloid leukemia, Investment, Region, Lymphatic system, Classification, FLT3, Daiichi Sankyo, Biology, FDA, CAGR, CRL, Adult, Crenolanib, Country, Name, Endpoint security, Industry, Drug development, Astellas Pharma, Growth, Patient, Pharmaceutical industry, Gilteritinib, Limited

The "FLT3 Inhibitors Market - A Global and Country Analysis: Focus on Commercialized Therapy, Potential Pipeline Product, and Region - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "FLT3 Inhibitors Market - A Global and Country Analysis: Focus on Commercialized Therapy, Potential Pipeline Product, and Region - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.
  • The current study aims to assess the global FLT3 inhibitors market by focusing on the marketed and potential pipeline therapies.
  • Increasing investments in the research and development of drug manufacturing are one of the major opportunities in the global FLT3 inhibitors market.
  • The growing interest of the pharmaceutical industry in the therapeutic potential for treating blood cancers with FLT3 positive mutations has been a catalyst for the progress of the global FLT3 inhibitors market.