Abbreviated New Drug Application

Techdow USA Announces Launch of its Generic Lovenox®, (Enoxaparin Sodium – Preservative Free) in Prefilled Syringes

Retrieved on: 
Thursday, June 8, 2023
General Health, Medical Devices, Health, Pharmaceutical, Medical Supplies, Abbreviated New Drug Application, Heparin, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., USP, Sale, Blood, Oligosaccharide, Thrombosis, RLD, Enoxaparin sodium, LMWH, Sanofi, FDA, Syringe, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Generic drug, Fine chemical

Techdow USA Inc. (“Techdow USA”), a growing market leader and vertically integrated generic injectables company, today announced the launch of its 30mg, 40mg, 60mg, 80mg, 100mg, 120mg, and 150mg strengths of generic Enoxaparin Sodium (Preservative Free) Prefilled Syringes, a therapeutic equivalent for the reference listed drug (RLD) Lovenox® (Preservative Free) from Sanofi-Aventis US LLC.

Key Points: 
  • Techdow USA Inc. (“Techdow USA”), a growing market leader and vertically integrated generic injectables company, today announced the launch of its 30mg, 40mg, 60mg, 80mg, 100mg, 120mg, and 150mg strengths of generic Enoxaparin Sodium (Preservative Free) Prefilled Syringes, a therapeutic equivalent for the reference listed drug (RLD) Lovenox® (Preservative Free) from Sanofi-Aventis US LLC.
  • Enoxaparin Sodium (Preservative Free) Prefilled Syringes had US brand and generic sales of approximately $530 million, according to IQVIA Health over a 12-month period ending March 2023.
  • Techdow USA’s Enoxaparin Sodium (Preservative Free) Prefilled Syringes are supplied in 10-pack single-dose for subcutaneous (SQ) use.
  • Techdow USA is among the fastest growing companies in the US generic pharmaceutical industry, specializing in the sale of generic injectable pharmaceuticals.

ANI Pharmaceuticals Announces FDA Approval and Commercialization of Two ANDAs with CGT Exclusivity

Retrieved on: 
Monday, May 15, 2023
Biotechnology, FDA, Pharmaceutical, Health, Abbreviated New Drug Application, CGT, ANI, Food and Drug Administration, Capsule, RLD, Alendronic acid, Anders, Food, Pharmaceutical industry, IQVIA

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 Applications (ANDAs) for Methsuximide Capsules USP, 300 mg and Alendronate Sodium Oral Solution 70 mg (base)/75 mL.

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 Applications (ANDAs) for Methsuximide Capsules USP, 300 mg and Alendronate Sodium Oral Solution 70 mg (base)/75 mL.
  • Methsuximide Capsules has been granted 180-day Competitive Generic Therapy (CGT) Exclusivity, and Alendronate Sodium Oral Solution is eligible for CGT Exclusivity upon launch.
  • ANI’s Methsuximide Capsules are the generic version of the Reference Listed Drug (RLD) Celontin® Capsules and ANI’s Alendronate Sodium Oral Solution is the generic version of the RLD Fosamax® Oral Solution.
  • "The FDA approval and launch of Methsuximide Capsules and Alendronate Sodium Oral Solution represent our ability to drive generics business growth through superior new product launch execution.

Vanda Pharmaceuticals Sues Federal Government for Misappropriation of Trade Secrets and Confidential Information

Retrieved on: 
Tuesday, May 2, 2023
United States Court of Federal Claims, Food, Abbreviated New Drug Application, Federation, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Vanda, Generic drug, Pharmaceutical industry

WASHINGTON, May 2, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced its action against the federal government for the uncompensated taking and misuse of Vanda's trade secrets and confidential information.

Key Points: 
  • WASHINGTON, May 2, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced its action against the federal government for the uncompensated taking and misuse of Vanda's trade secrets and confidential information.
  • Vanda alleges that the U.S. Food and Drug Administration (FDA) improperly provided confidential details from Vanda's drug master files for its products, HETLIOZ® and Fanapt®, to generic drug manufacturers during the FDA's review of the manufacturers' Abbreviated New Drug Applications.
  • The action was filed in the United States Court of Federal Claims and seeks an award of economic damages.
  • A copy of the complaint can be found here (Vanda Pharmaceuticals Inc. v. USA, case no.

The Ritedose Corporation Begins production of Drug to Alleviate National Medication Shortage

Retrieved on: 
Tuesday, April 25, 2023
COPD, Akorn, Abbreviated New Drug Application, Asthma, Chastain, Inhalation, Chronic obstructive pulmonary disease, Hospital, Salbutamol, CGMP, Patient, COVID-19 pandemic, ANDA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BFS, Food, Pharmaceutical industry

COLUMBIA, S.C., April 25, 2023 /PRNewswire/ -- The Ritedose Corporation (Ritedose), an industry leader in pharmaceutical development, aseptic cGMP manufacturing and 503B outsourcing solutions, has begun production of a particular form of Albuterol Sulfate that the FDA has listed in short supply in the United States. It will be available in May.

Key Points: 
  • In March, the U.S. Food and Drug Administration (FDA) announced a drastic downturn in the nation's supply of Albuterol Sulfate (0.5% Inhalation Solution).
  • "Major shifts in the market's ability to meet demand has driven our rapid response," said Jody Chastain, CEO of The Ritedose Corporation.
  • "We are all about patient safety and reliability—the U.S. can count on us to step-up and solve the drug shortage gap of Albuterol Sulfate."
  • For long-term supply chain continuity, Ritedose will be submitting an additional Abbreviated New Drug Application (ANDA) in other container sizes to meet supply demands.

ANI Pharmaceuticals Announces the FDA Approval and Launch of Nitrofurantoin Oral Suspension USP

Retrieved on: 
Monday, April 24, 2023
Biotechnology, FDA, Pharmaceutical, Health, Abbreviated New Drug Application, ANI, Food and Drug Administration, RLD, ANDA, Food, 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 Nitrofurantoin Oral Suspension USP, 25 mg/5 ml.

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 Nitrofurantoin Oral Suspension USP, 25 mg/5 ml.
  • ANI’s Nitrofurantoin Oral Suspension is the generic version of the Reference Listed Drug (RLD) Furadantin® Oral Suspension 25 mg/5 ml.
  • The current annual U.S. market for Nitrofurantoin Oral Suspension is approximately $55.5 million, according to the latest estimates by IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • The FDA approval and commercialization of Nitrofurantoin Oral Suspension is another example of how we are continuing to bring limited-competition products to market, with the goal of serving the patient populations that can benefit,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

ANI Pharmaceuticals Announces the FDA Approval of Colestipol Hydrochloride Tablets USP

Retrieved on: 
Tuesday, April 4, 2023
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Abbreviated New Drug Application, ANI, Food and Drug Administration, Tablet, RLD, Patient, ANDA, Food, Generic drug, Colestipol

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 Colestipol Hydrochloride Tablets USP, 1 g.

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 Colestipol Hydrochloride Tablets USP, 1 g.
    ANI’s Colestipol Hydrochloride Tablets are the generic version of the Reference Listed Drug (RLD) Colestid®.
  • The current annual U.S. market for Colestipol Hydrochloride Tablets is approximately $81.3 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • "We are pleased to expand our generics portfolio with the launch of Colestipol, bringing to market a product with a limited number of suppliers.
  • We remain committed to providing patients access to high-quality medicines,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

Incyte Provides Regulatory Update on Ruxolitinib Extended-Release Tablets

Retrieved on: 
Friday, March 24, 2023
FDA, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Graft-versus-host disease, Ruxolitinib, GVHD, Polycythemia vera, Abbreviated New Drug Application, New Drug Application, NDA, PV, QD, Tablet, Pancreatic serous cystadenoma, BID, AUC, XR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Generic drug

“While we are disappointed that the FDA issued a complete response letter for ruxolitinib extended-release tablets, we remain committed to advancing care for people with myeloproliferative neoplasms and GVHD,” said Hervé Hoppenot, Chief Executive Officer, Incyte.

Key Points: 
  • “While we are disappointed that the FDA issued a complete response letter for ruxolitinib extended-release tablets, we remain committed to advancing care for people with myeloproliferative neoplasms and GVHD,” said Hervé Hoppenot, Chief Executive Officer, Incyte.
  • “We will work closely with the FDA on the appropriate next steps to address their comments.”
    The NDA was based on two studies designed to show that ruxolitinib XR tablets are dosage strength proportional and bioequivalent to Jakafi® (ruxolitinib) tablets.
  • The first study was designed to determine the relative bioavailability of ruxolitinib XR tablets to Jakafi tablets and to demonstrate that ruxolitinib XR tablets are dosage strength proportional to Jakafi tablets.
  • Study results demonstrated that ruxolitinib XR 50 mg tablets dosed QD is bioequivalent to Jakafi 25 mg tablets dosed BID, based on AUC parameters.

EQS-News: Newron announces 2022 financial results and provides outlook for 2023

Retrieved on: 
Thursday, March 16, 2023
Sympathetic nervous system, Annual report, Sale, PD, Sustainable Development Goals, Peripheral nervous system, Clozapine, Trial of the century, Levodopa-induced dyskinesia, Partnership, Orange Book, XETRA, Abbreviated New Drug Application, Paragraph, Environment, Schizophrenia, Phase, Clinical Global Impression, Patient, UN, Positive and Negative Syndrome Scale, Tablet, Psychosis, FDA, Sustainability, TRS, Social, US Foods, EUR, Sustainable development, ESG, Safety, CET, Positive, Annual, AGM, Food, Social Security Government Pension Offset, PANSS, Intellectual property, R, Pharmaceutical industry, Nursing, Cryptocurrency, Newron Cup

Milan, Italy, March 14, 2023, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.

Key Points: 
  • Milan, Italy, March 14, 2023, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.
  • The results showed that the addition of evenamide improved symptoms of psychosis in patients with TRS.
  • Recruitment at treatment centers in Europe, Asia and Latin America is ongoing and results are expected in 2023.
  • ESG focus areas and objectives for 2023 have been defined and Newron’s Annual ESG reporting efforts commence with the Annual Report 2022 published today.

Newron Announces 2022 Financial Results and Provides Outlook For 2023

Retrieved on: 
Tuesday, March 14, 2023
Mental Health, Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, PANSS, Orange Book, Sustainability, Annual report, Tablet, Peripheral nervous system, Psychosis, TRS, Intellectual property, Positive, ESG, XETRA, Social, EUR, Clinical Global Impression, Environment, Abbreviated New Drug Application, Levodopa-induced dyskinesia, PD, Annual, Sale, Social Security Government Pension Offset, Patient, Schizophrenia, UN, Food, Clozapine, Medication, Paragraph, Trial of the century, Safety, R, Phase, FDA, AGM, Sympathetic nervous system, Positive and Negative Syndrome Scale, Sustainable Development Goals, Sustainable development, Partnership, US Foods, Pharmaceutical industry, Nursing, Cryptocurrency, Newron Cup

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.

Key Points: 
  • Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.
  • The results showed that the addition of evenamide improved symptoms of psychosis in patients with TRS.
  • Recruitment at treatment centers in Europe, Asia and Latin America is ongoing and results are expected in 2023.
  • ESG focus areas and objectives for 2023 have been defined and Newron’s Annual ESG reporting efforts commence with the Annual Report 2022 published today.

Amneal Announces U.S. FDA Filing Acceptance of Abbreviated New Drug Application for Naloxone Hydrochloride Nasal Spray, USP, 4mg

Retrieved on: 
Thursday, March 2, 2023
Biotechnology, FDA, Pharmaceutical, Health, NYSE, ANDA, Medication, Amneal Pharmaceuticals, Public, Regulation of tobacco by the U.S. Food and Drug Administration, Abbreviated New Drug Application, USP, Food, Naloxone, Pharmaceutical industry

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and is used in the treatment of a known or suspected opioid overdose emergency.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and is used in the treatment of a known or suspected opioid overdose emergency.
  • “Naloxone hydrochloride nasal spray is a critical tool in addressing the opioid public health emergency across the United States,” said Andy Boyer, Chief Commercial Officer, Amneal Generics.
  • “We are well prepared to launch this product at a significant scale and substantially increase access to this life-saving medicine as we work to help combat this endemic crisis.”
    According to IQVIA®, U.S. annual sales for this product for the 12 months ended December 2022 were $318 million.
  • In addition, there are significant volumes of the product purchased directly by U.S. states.