Abbreviated New Drug Application

Taro Provides Results for the Quarter Ended June 30, 2022

Retrieved on: 
Wednesday, July 27, 2022
Biotechnology, Pharmaceutical, Medical Supplies, General Health, Health, FDA, Genetics, Other Health, Regulation of tobacco by the U.S. Food and Drug Administration, Acquisition, R, MDL, Court, Industry, Research, Food, Forward-looking statement, NYSE, SEC, DPP, Private Securities Litigation Reform Act, Marketing, MDL Information Systems, Income, Language, Abbreviated New Drug Application, Mission statement, FDA, Company, Growth, Pharmaceutical industry, Insurance, Cryptocurrency, Generic drug

Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (Taro or the Company) today provided unaudited financial results for the quarter ended June 30, 2022.

Key Points: 
  • Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (Taro or the Company) today provided unaudited financial results for the quarter ended June 30, 2022.
  • Quarter ended June 30, 2022* Highlights compared to June 30, 2021
    Net sales increased $9.6 million, or 6.5%, to $156.7 million.
  • Cash flow used in operations for the quarter ended June 30, 2022, was $58.0 million.
  • * The June 30, 2022 results include three months results from the February 28th acquisition of Alchemee.

Tris Pharma announces U.S. Court of Appeals for the Federal Circuit Affirms Validity of Quillivant XR® Patents; Rules Teva Infringes Tris Patents

Retrieved on: 
Wednesday, July 20, 2022
Ketan, XR, Multiple sclerosis, Chest pain, ANDA, Attention deficit hyperactivity disorder predominantly inattentive, Federal Circuit Court of Australia, Priapism, Research, The, Raynaud syndrome, Ventricular septal defect, Hydrogen chloride, List, Finger, CNS, Methylphenidate, Spasticity, Narcolepsy, Lists of diseases, Tris, Boxed warning, Degenerative disease, Numb, Suicide, ADHD, Abbreviated New Drug Application, Peripheral vasculopathy, Mania, CII, CAFC, Patient, Cerebral palsy, Psychosis, Pain, Color, Depression, United States Court of Appeals for the Federal Circuit, Attention deficit hyperactivity disorder, MAOI, District, Attention, Breast milk, United States district court, Actavis, Child, Generic drug, Risk management, Pharmaceutical industry, Medical device, Residential care, Birth control, Healthcare

"We are very pleased with the ruling of the CAFC, which affirms the strength of our patents protecting Quillivant XR.

Key Points: 
  • "We are very pleased with the ruling of the CAFC, which affirms the strength of our patents protecting Quillivant XR.
  • You and your doctor should decide if you will take Quillivant XR or breastfeed
    What should I avoid while taking Quillivant XR?
  • Quillivant XR should not be taken with MAOI medicines or if you stopped taking an MAOI in the last 14 days.
  • Quillivant XR may cause serious side effects, including:
    Other serious side effects include:
    Painful and prolonged erections (priapism) have occurred with methylphenidate.

Lachman Consultant Services, Inc. Names Marty Shimer as Executive Director, Regulatory

Retrieved on: 
Monday, July 11, 2022
OGD, Control, Regulatory affairs, FDA, Pulitzer Prize Special Citations and Awards, AMA Foundation Leadership Award, U.S. Public Health Service reorganizations of 1966–1973, CEO, Industry, Commendation Medal, Medication, Commissioner, Food, Knowledge, Abbreviated New Drug Application, Lachmann, Patent, Division, Science and technology, Consultant, United States Public Health Service, Achievement, Compliance, Technology, Pharmacy (shop), II, ANDA, Anders (singer), PET, PHS, Development aid, Publication, Organization, Risk management, Pharmaceutical industry, Biotechnology, Science, Device

WESTBURY, N.J., July 11, 2022 /PRNewswire-PRWeb/ -- In this role, Mr. Shimer will assist clients with regulatory submissions and strategy, communications with FDA, and navigating the approval process while offering guidance on issues related to therapeutic equivalence, patent certifications, 180-day exclusivity, the Competitive Generic Therapy pathway, New Drug Application exclusivities, regulatory requirements for ANDAs and more.

Key Points: 
  • Frances Zipp, President and CEO of Lachman Consultant Services, Inc. (Lachman Consultants), a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, announced today that CAPT Martin H. Shimer, II joined the firm as Executive Director, Regulatory, effective July 11, 2022.
  • His time with the FDA also included roles as Senior Supervisory Regulatory Management Officer, Deputy Director; Supervisory Regulatory Management Officer, Branch Chief; and Senior Regulatory Management Officer.
  • During his time with the FDA, Mr. Shimer actively supported a range of important public health initiatives, both domestically and abroad.
  • Founded in 1978, Lachman Consultants maintains three practice groups: Compliance, Regulatory Affairs, and Science and Technology.

Sollievo Pharmaceuticals, Inc. Announces a Breakthrough in Intramuscular Sedation of Agitated and Violent Patients

Retrieved on: 
Tuesday, July 5, 2022
Hospitals, Pharmaceutical, Health, Other Health, Health, FDA, Abbreviated New Drug Application, Patient, CEO, Agitation, COVID, Violence, Â, ED, Industry, Emergency department, Verbal abuse, Risk, Nursing, Absorption, Casa Sollievo della Sofferenza, Medication, Hospital, Pharmaceutical industry, Avizafone

The onset of sedation from current injectable products is unreliable, with sedation ranging from five to 45 minutes.

Key Points: 
  • The onset of sedation from current injectable products is unreliable, with sedation ranging from five to 45 minutes.
  • Sollievo believes there is strong evidence that its proprietary formulation can more rapidly and consistently sedate aggressive patients.
  • While consistent sedation must begin with consistent drug delivery, Sollievos breakthrough formulation is an invaluable advancement for an industry where every minute matters.
  • An intramuscular injection capable of rapidly and consistently de-escalating violent patients would see significant usage in this challenging environment.

Glenmark Pharmaceuticals Inc., USA continues to expand its Over-The-Counter (OTC) Portfolio with the acquisition of approved ANDAs from Wockhardt Limited

Retrieved on: 
Tuesday, June 28, 2022
Dermatology, Glenmark, OTC, Acquisition, Patient, Anders (singer), BSE, Dow Jones, Growth, Ethics in pharmaceutical sales, Abbreviated New Drug Application, Social media, NSE, Social, DJSI, Generic, Generic drug

Glenmark's current portfolio consists of 175 products authorized for distribution in the U.S. marketplace and 48 ANDAs pending approval with the U.S. FDA.

Key Points: 
  • Glenmark's current portfolio consists of 175 products authorized for distribution in the U.S. marketplace and 48 ANDAs pending approval with the U.S. FDA.
  • In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
  • Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is an innovation-driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses.
  • The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries.

ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium Tablets USP

Retrieved on: 
Wednesday, June 22, 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 Clorazepate Dipotassium Tablets.

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 Clorazepate Dipotassium Tablets.
  • ANIs Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.
  • The current annual U.S. market for Clorazepate Dipotassium Tablets is approximately $25.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • The imminent launch and commercialization of Clorazepate Dipotassium Tablets is another example of our ongoing commitment to ensuring that patients in need have access to important therapeutics, stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

ANI Pharmaceuticals Announces the FDA Approval and Imminent Launch of Fludrocortisone Acetate Tablets USP

Retrieved on: 
Wednesday, June 1, 2022
Biotechnology, FDA, Pharmaceutical, Health, Abbreviated New Drug Application, Company, Health, Research, Marketing, Form 10-K, Food, Tablet, Annual report, Nature, RLD, News, Security (finance), U.S. Securities and Exchange Commission, Failure, Nasdaq, ANDA, Growth, Patient, Private Securities Litigation Reform Act, Risk, Food and Drug Administration, SEC, Regulation of tobacco by the U.S. Food and Drug Administration, Terminology, ANI, 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 Fludrocortisone Acetate Tablets USP, 0.1 mg.

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 Fludrocortisone Acetate Tablets USP, 0.1 mg.
    ANIs Fludrocortisone Acetate Tablets are the generic version of the Reference Listed Drug (RLD) Florinef.
  • The current annual U.S. market for Fludrocortisone Acetate Tablets, 0.1 mg is approximately $24.2 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.
  • Uncertainties and risks may cause the Companys actual results to be materially different than those expressed in or implied by such forward-looking statements.

CPHI China opens for international partnering after China rises in CPHI Index

Retrieved on: 
Monday, June 6, 2022
Online, Life, Abbreviated New Drug Application, Association, FDF, Health, Pennsylvania Convention Center, Research, Exhibition, Fashion, IMPACT, Bioproduction, Food, Health care, MAH, Ministry of Health, Nutrition and Indigenous Medicine, API, Growth, Real estate, Medication, Murina, ICSE, National Capital Region (India), Paris Expo Porte de Versailles, Online and offline, Construction, Fine chemical, Video game, Messe Frankfurt

SHANGHAI, June 6, 2022 /PRNewswire/ -- CPHI & P-MEC China opens its online international partnering platform as pharmaceutical and biopharmaceutical industries in the country report strong underlying conditions and see increases in all categories of the most recent CPHI Pharma Index[1] – an annual score of each country's pharma industry strength – with its overall score rising by 7.2%, the largest increase of any nation.

Key Points: 
  • The two-month digital partnering platform takes on increased importance with the postponement of the in-person exhibition until December (20th-22nd) 2022.
  • High quality partners are in great demand and we wanted to simplify process of nurturing new contacts," commentedLaura Murina, Brand Manager at CPHI & P-MEC China.
  • China recorded the largest year-on-year gains in the CPHI Pharma Index[2] for 'solid dose manufacturing innovation', 'quality of bioprocessing' and 'API manufacturing' with rises of 9.5%, 11% and 7.4% respectively and international companies should anticipate the need to source partners much earlier as demand rises.
  • CPHI & P-MEC China is encouraging all international attendees to utilise its Hosted Buyer Programme.

Taro Provides Results for the Year Ended March 31, 2022

Retrieved on: 
Friday, May 27, 2022
Health, Pharmaceutical, Department, Abbreviated New Drug Application, Interest, United States Department of Justice Antitrust Division, Income, Company, R, FX, Private Securities Litigation Reform Act, Regulation of tobacco by the U.S. Food and Drug Administration, Research, Food, Taro, Foreign exchange market, Environment, Mission statement, Language, DOJ, D, Marketing, FDA, Industry, Forward-looking statement, TPC, SG, Acne, Acquisition, SEC, NYSE, Skin care, Pharmaceutical industry, Online gambling, Fine chemical, Insurance, Reinsurance, Cryptocurrency, Galderma

Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (Taro or the Company) today provided unaudited financial results for the quarter and year ended March 31, 2022.

Key Points: 
  • Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (Taro or the Company) today provided unaudited financial results for the quarter and year ended March 31, 2022.
  • Quarter ended March 31, 2022 Highlights compared to March 31, 2021
    The quarter ended March 31, 2022, includes one months results from the February 28th acquisition of Alchemee.
  • Year ended March 31, 2022 Highlights compared to March 31, 2021
    The year ended March 31, 2022, includes one months results from the February 28th acquisition of Alchemee.
  • Cash flow used in operations for the year ended March 31, 2022, was $158.7 million.

Cosette Pharmaceuticals and Alembic Pharmaceuticals Limited Announce the Approval and Launch of a National Brand Equivalent (NBE) of Abreva® (Docosanol Cream 10%) Including the First Approval in the Pump Format

Retrieved on: 
Tuesday, May 24, 2022
FDA, Pharmaceutical, Health, Clinical Trials, Abbreviated New Drug Application, Health, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Multimedia, NBE, Joint Medical Service (Germany), Patient, 1-Docosanol, Avista Capital Partners, GM, Suppository, NSE, Research, FDA, Alembic Pharmaceuticals, Medication, ANDA, APLL, Alembic, BSE, USFDA, Reuters, Private label, TD, MD, CEO, Generic drug

This approval represents the first ANDA approval in the pump format and Cosette plans to launch the product across the US retail channel.

Key Points: 
  • This approval represents the first ANDA approval in the pump format and Cosette plans to launch the product across the US retail channel.
  • Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations.
  • Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
  • Information about Alembic can be found at http://www.alembicpharmaceuticals.com/ ; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (BSE: 533573)
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220524005173/en/