Abbreviated New Drug Application

Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream

Retrieved on: 
Monday, April 1, 2024
Cream, Psoriasis, Abbreviated New Drug Application, NESS, Partnership, District court, Patient, Nevoid basal-cell carcinoma syndrome, Dermatology, Patent, IQVIA, FDA, Sol–gel process, Food, Generic drug

On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.

Key Points: 
  • On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.
  • Annual market sales for Zoryve Cream, 0.3% were approximately $95 million in the 12 months ended in January 2024, as measured by IQVIA.
  • Should its ANDA for Roflumilast Cream, 0.3% be approved by the FDA, Padagis believes that its product may be entitled to 180 days of generic market exclusivity.
  • Submissions such as Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic value of Sol-Gel’s partnership with Padagis.

Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

Retrieved on: 
Monday, March 25, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, AOE, Otitis externa, Patient, Dexamethasone, Ciprofloxacin, Abbreviated New Drug Application, Pseudomonas aeruginosa, Medication, Infection, Staphylococcus aureus, Amneal Pharmaceuticals, Food

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.
  • “This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics.
  • “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”
    The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%).
  • For full prescribing information, see package insert located here .

WIT Legal Releases New Report on 2023 Activities and Trends in Hatch-Waxman Litigation

Retrieved on: 
Wednesday, March 20, 2024
Orange Book, New Drug Application, Orange, Patent, Abbreviated New Drug Application, WIT, NDA, Johnson & Johnson, Generic drug

NEW YORK, March 20, 2024 /PRNewswire/ -- WIT Legal ("WIT"), the leading agency representing testifying experts for high-stakes, complex legal matters, today released a new report that evaluates 2023 Hatch-Waxman Litigation.

Key Points: 
  • NEW YORK, March 20, 2024 /PRNewswire/ -- WIT Legal ("WIT"), the leading agency representing testifying experts for high-stakes, complex legal matters, today released a new report that evaluates 2023 Hatch-Waxman Litigation.
  • The new WIT report examines Abbreviated New Drug Application (ANDA) cases and the Orange Book-listed products at issue.
  • "Our intent is to provide the most comprehensive review of true ANDA litigation available," said Michael Connelly, WIT President.
  • Additionally, the report goes beyond the specific companies involved to provide insight into the corporate families driving ANDA litigation to highlight potential market dynamics and litigation trends.

Exelixis Announces Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 6, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Molecule, Royalty payment, Conference, Liver disease, Calendar, Breast, Immunotherapy, RCC, PIN, ASCO, NHT, Progression-free survival, Safety, FDA, PLK4, ADC, ITT, PKMYT1, Associate, University, Baylor University, PARP, USP1, Society, Neck, Science, Acquisition, Biology, Superior, Huntsman Cancer Institute, Dean (education), Metastasis, PFS, Translational research, Drug development, Distinguishing, Head, Food, NET, Baylor College of Medicine, Cancer, Share repurchase, BIRC, OS, SCCHN, Neoplasm, Congress, National Cancer Institute, Abbreviated New Drug Application, Research, Docetaxel, Translation, Prostate cancer, Therapy, ESMO, Education, Experiment, Checkmate, Pharmaceutical industry

In 2023, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $2.2 billion.

Key Points: 
  • In 2023, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $2.2 billion.
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2023, Exelixis earned $40.7 million and $148.5 million, respectively, in royalty revenues.
  • In October 2023, detailed results were presented from the phase 3 CABINET pivotal trial at the 2023 ESMO Congress.
  • Exelixis management will discuss the company’s financial results for the fourth quarter and fiscal year of 2023 and provide a general business update during a conference call beginning at 5:00 p.m.

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

Retrieved on: 
Tuesday, January 16, 2024
CGT, Patient, OS, ANI, Health, Food and Drug Administration, USP, RLD, Food, Indometacin, FDA, Abbreviated New Drug Application, Pharmaceutical industry

BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  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 Indomethacin Oral Suspension (OS), USP.

Key Points: 
  • BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  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 Indomethacin Oral Suspension (OS), USP.
  • ANI’s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension.
  • The current annual U.S. market for Indomethacin OS is approximately $4.1 million, according to the latest estimates from IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • "With this approval, the FDA has granted Indomethacin OS a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity.

Avenacy Announces Launch of Melphalan Hydrochloride for Injection in the U.S. Market

Retrieved on: 
Tuesday, January 16, 2024
Biotechnology, General Health, FDA, Health, Pharmaceutical, Entrepreneurship, Patient, Hospital, Temperature, Anaphylaxis, Food, Multiple myeloma, Chromosome, Human, Melphalan, Safety, Bone marrow, Boxed warning, Bleeding, Aplastic anemia, Infection, Abbreviated New Drug Application, Pharmaceutical industry

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Melphalan Hydrochloride for Injection in the United States as a therapeutic equivalent generic for Alkeran® for Injection (melphalan hydrochloride) approved by the U.S. Food and Drug Administration.

Key Points: 
  • Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Melphalan Hydrochloride for Injection in the United States as a therapeutic equivalent generic for Alkeran® for Injection (melphalan hydrochloride) approved by the U.S. Food and Drug Administration.
  • Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
  • Avenacy’s Melphalan Hydrochloride for Injection is available in a kit containing a 50mg vial of lyophilized active ingredient and a 10mL vial of sterile diluent for admixture.
  • “Melphalan Hydrochloride for Injection will feature our proprietary product packaging and labeling, supporting our commitment to championing reliability, safety, and convenience for our customers.

Lantheus Announces Acceptance of its First-to-File ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate)

Retrieved on: 
Thursday, January 11, 2024
Glomus tumor, Paragraph, Somatostatin, DOTA-TATE, Food, LNTH, FDA, Abbreviated New Drug Application, Certification

LUTATHERA® is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Key Points: 
  • LUTATHERA® is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
  • Based on the most recent update to the FDA’s online paragraph IV database listings,1 Lantheus believes it is the first applicant to have filed a substantially complete ANDA for Lutetium Lu 177 Dotatate containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act.
  • Should its ANDA be approved by the FDA, Lantheus believes it will be eligible for 180 days of generic marketing exclusivity in the U.S.
    Lantheus licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2003 from POINT Biopharma Global, Inc. in December of 2022.
  • To read the press release announcing that licensing transaction, please click here .

PharmaTher Provides Update for Expected FDA Approval of Ketamine

Retrieved on: 
Wednesday, January 10, 2024
ALS, Hospital, Suicidal ideation, Anesthesia, CGMP, DEA, Mental health, Complex regional pain syndrome, Anxiety, Ketamine, Food, Pain, Rett syndrome, FDA, DSM-IV codes, Health Canada, Abbreviated New Drug Application, Depression, Pharmaceutical industry

The assigned FDA approval goal date is still on track.

Key Points: 
  • The assigned FDA approval goal date is still on track.
  • Fabio Chianelli, CEO of PharmaTher, commented: “We believe 2024 will be a transformative year for PharmaTher with the expected FDA approval of ketamine having an assigned goal date for approval on April 29, 2024.
  • On October 10, 2023, the FDA published a compounding risk alert describing the potential risks associated with compounded ketamine products for psychiatric disorders, specifically from telehealth providers that provide in-home ketamine services.
  • Following the FDA approval and launch in the U.S., the Company will pursue international approvals to support the global demand for ketamine.

Delaware Federal District Court Rules in Favor of Acadia Pharmaceuticals in NUPLAZID® (pimavanserin) Patent Litigation

Retrieved on: 
Wednesday, December 13, 2023
Biotechnology, Pharmaceutical, Health, Neurology, ANDA, Disorder, Laboratory, ACAD, District court, Abbreviated New Drug Application, Court, Generic drug, Acadia Pharmaceuticals

(Nasdaq: ACAD) today announced that the U.S. District Court for the District of Delaware has granted summary judgment to Acadia, confirming validity of the NUPLAZID® (pimavanserin) '740 composition of matter patent.

Key Points: 
  • (Nasdaq: ACAD) today announced that the U.S. District Court for the District of Delaware has granted summary judgment to Acadia, confirming validity of the NUPLAZID® (pimavanserin) '740 composition of matter patent.
  • The court ruled in favor of Acadia on all grounds.
  • Ltd., MSN Pharmaceuticals, Inc. and other ANDA (Abbreviated New Drug Application) filers and concludes this litigation in the District Court.
  • “We are very pleased that the Court has made its final decision on this matter, ruling strongly in favor of Acadia.

A.forall Announces Launch of a Generic Version of Pyridostigmine Bromide Syrup

Retrieved on: 
Monday, December 11, 2023
FDA, Pharmaceutical, Health, Pyridostigmine, ANDA, Food, Abbreviated New Drug Application, Acella, Patient, Multimedia, Myasthenia gravis, Neurology, Muscle weakness, Muscle fatigue, Generic drug, Pharmaceutical industry

Milla Pharmaceuticals Inc. , an A.forall company, announced that its partner, Acella Pharmaceuticals LLC , has just commercialized its Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Mestinon® (Pyridostigmine Bromide Syrup) 60 mg/5mL.

Key Points: 
  • Milla Pharmaceuticals Inc. , an A.forall company, announced that its partner, Acella Pharmaceuticals LLC , has just commercialized its Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Mestinon® (Pyridostigmine Bromide Syrup) 60 mg/5mL.
  • View the full release here: https://www.businesswire.com/news/home/20231211602217/en/
    Pyridostigmine Bromide Syrup is indicated for symptomatic treatment of myasthenia gravis.
  • This achievement marks the third ANDA commercialization for Milla Pharmaceuticals Inc. and the fourth for an A.forall product in the U.S. market.
  • With all other projects in our pipeline, our team looks forward to continuing that trend and turning our mission into reality.”
    Acella is excited to partner with Milla Pharmaceuticals on the commercialization of the Pyridostigmine Bromide Syrup.