Abbreviated New Drug Application

Perrigo Announces FDA Approval of the Store Brand OTC Equivalent of Advil® Dual Action Tablets

Retrieved on: 
Wednesday, March 1, 2023
Marketing, Ibuprofen, IRI, Safety, Perrigo, NYSE, Tablet, OTC, FDA, Paracetamol, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PRGO, ANDA, Consumer, Abbreviated New Drug Application, Food, Generic drug

DUBLIN, March 1, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg, the store brand over-the-counter ("OTC") equivalent of Advil® Dual Action Tablets 250 mg/125 mg.

Key Points: 
  • DUBLIN, March 1, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg, the store brand over-the-counter ("OTC") equivalent of Advil® Dual Action Tablets 250 mg/125 mg.
  • This approval was received on the first day possible following the expiration of the marketing exclusivity for Advil® Dual Action Tablets 250 mg/125 mg."
    Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg provides relief for multiple pain related symptoms by combining two ingredients indicated for OTC pain relief.
  • Retail sales for the national brand equivalent product for the last twelve months ending January 29, 2023, were approximately $69 million based on IRI multi-outlet market data.
  • Important safety information about Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg
    Before using the product, consumers should read the Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg drug facts label.

Cosette Pharmaceuticals Announces the Approval and Launch of Metronidazole Gel USP, 1%

Retrieved on: 
Thursday, February 9, 2023
FDA, General Health, Pharmaceutical, Health, Abbreviated New Drug Application, Food, Multimedia, Use, Regulation of tobacco by the U.S. Food and Drug Administration, USP, ANDA, Full, Medication, Fine chemical

Cosette Pharmaceuticals, Inc. ("Cosette") announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for Metronidazole Gel USP, 1%.

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 Metronidazole Gel USP, 1%.
  • View the full release here: https://www.businesswire.com/news/home/20230209005033/en/
    This launch will enable Cosette to continue to build upon its unparalleled quality track record and leverage its United States based manufacturing site in Lincolnton, NC.
  • Apurva Saraf, President and CEO of Cosette Pharma, stated, "The continued approval and launches of our internal R&D programs highlights our commitment to world class R&D and operational excellence.
  • See the Full Prescribing Information and Instructions for Use for Metronidazole Gel, USP 1% at www.dailymed.com .

Catalyst Pharmaceuticals Notified of Abbreviated New Drug Application Filing for FIRDAPSE®

Retrieved on: 
Monday, January 23, 2023
Federal Food, Drug, and Cosmetic Act, Drug, ANDA, Food, Certification, Catalyst Pharmaceuticals, Teva Pharmaceuticals, Notice, Abbreviated New Drug Application, Sale, Patient, Patent, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Paragraph, Judgement, Drug Price Competition and Patent Term Restoration Act, Catalysis, Degenerative disease, CORAL, Generic drug, Teva

CORAL GABLES, Fla., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that it has received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Teva Pharmaceuticals, Inc. ("Teva") advising that Teva had submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") seeking authorization from the FDA to manufacture, use or sell a generic version of FIRDAPSE® in the United States.

Key Points: 
  • CORAL GABLES, Fla., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that it has received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Teva Pharmaceuticals, Inc. ("Teva") advising that Teva had submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") seeking authorization from the FDA to manufacture, use or sell a generic version of FIRDAPSE® in the United States.
  • In the Notice Letter, Teva states that it intends to market a generic version of FIRDAPSE® before the expiration of Catalyst’s patents listed in the FDA Orange Book covering FIRDAPSE®: U.S. Patent Numbers 10,626,088 (expiring February 2037); 10,793,893 (expiring May 2034); 11,060,128 (expiring June 2032); 11,268,128 (expiring June 2032); 11,274,331 (expiring June 2032); and 11,274,332 (expiring June 2032).
  • Teva’s Notice Letter states that its ANDA contains a Paragraph IV Certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Teva’s ANDA submission.
  • Under the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, Catalyst has 45 days from receipt of the Notice Letter to commence a patent infringement lawsuit in a federal district court against Teva to trigger a stay precluding FDA from approving Teva’s ANDA until May 2026 or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.

Exelixis Announces Update on Patent Litigation with MSN Laboratories

Retrieved on: 
Thursday, January 19, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Laboratory, United States District Court for the Eastern District of Texas, Orange Book, Orange, District court, General counsel, Abbreviated New Drug Application, Civil Actions Medal, ANDA, Douglas v. U.S. District Court ex rel Talk America, Consolidated, Patent, Patient, MSN, EXEL, Generic drug, Exelixis

Exelixis, Inc. (Nasdaq: EXEL) today announced that in the lawsuit Exelixis, Inc. (Exelixis) v. MSN Laboratories Private Limited et al.

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced that in the lawsuit Exelixis, Inc. (Exelixis) v. MSN Laboratories Private Limited et al.
  • 19-2017 (Consolidated), the U.S. District Court for the District of Delaware ruled in Exelixis’ favor, rejecting MSN’s challenge to the cabozantinib compound patent (U.S. 7,579,473).
  • “We are pleased the court upheld the validity of Exelixis’ cabozantinib compound patent,” said Jeffrey Hessekiel, J.D., Executive Vice President, General Counsel and Secretary, Exelixis.
  • This ruling does not impact Exelixis’ separate and ongoing suit against MSN, Exelixis, Inc. vs. MSN Laboratories Private Limited et al., Civil Action No.

FDA Grants Priority Review for Nalmefene Prefilled Syringe for the Treatment of Known or Suspected Opioid Overdose

Retrieved on: 
Wednesday, January 18, 2023
Mental Health, Medical Supplies, Medical Devices, FDA, Health, Pharmaceutical, Practitioner, Purdue University, Hypertension, Pulmonary edema, Oxygen, Buprenorphine, Nalmefene, Purdue Pharma, Safety, Abbreviated New Drug Application, Nursing, MD, HCI, Risk, Hypotension, Ventricular fibrillation, LAAM, ANDA, Methadone, Patient, Prevalence, Mortality, Tachycardia, Recurrence, Ventricular tachycardia, Hypersensitivity, Fentanyl, Hypoventilation, Naloxone, Physician, Pharmaceutical industry, Cereal, Generic drug

* Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in the management of known or suspected opioid overdose.

Key Points: 
  • * Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in the management of known or suspected opioid overdose.
  • In addition, FDA previously granted Competitive Generic Therapy designation for the prefilled syringe and the nalmefene hydrochloride injection vial.
  • There is no guarantee that nalmefene prefilled syringe will successfully complete development or gain FDA approval.
  • Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.

Amneal Announces 26 Generic New Product Launches in 2022 and First Injection Large Volume Bag Approval

Retrieved on: 
Tuesday, December 20, 2022
Biotechnology, Pharmaceutical, Health, Degenerative disease, Security (finance), Bromide, Patient, Central nervous system, Annual report, NYSE, Food, Common stock, Federation, Growth, SVP, COVID-19, Risk, Medication, Generic, FDA, Weather, Nasal spray, Amneal Pharmaceuticals, Sodium chloride, Tachycardia, Investment, Research, Abbreviated New Drug Application, Regulation of tobacco by the U.S. Food and Drug Administration, Pharmaceutical industry, Risk management

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the Company has successfully launched 26 new generic products in 2022.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the Company has successfully launched 26 new generic products in 2022.
  • Looking to 2023, we expect more than 30 new product launches,” said Chirag Patel and Chintu Patel, Amneal Co-Chief Executive Officers.
  • In addition, Amneal also announced it received Abbreviated New Drug Application approval from the U.S. Food and Drug Administration (“FDA”) for its first large volume bag, esmolol hydrochloride in sodium chloride injection.
  • According to IQVIA®, U.S. annual sales for this product for the 12 months ended October 2022 were $57 million.

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

Retrieved on: 
Monday, December 19, 2022
FDA, Health, Other Health, General Health, Pharmaceutical, Biotechnology, Security (finance), Tablet, Patient, Food, Food and Drug Administration, RLD, Form 10-K, Growth, COVID-19, Health, Marketing, Nature, Risk, FDA, Failure, News, ANDA, Annual report, ANI, Abbreviated New Drug Application, Regulation of tobacco by the U.S. Food and Drug Administration, 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 Levocarnitine Tablets USP, 330 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 Levocarnitine Tablets USP, 330 mg.
    ANI’s Levocarnitine Tablets are the generic version of the Reference Listed Drug (RLD) Carnitor®.
  • The current annual U.S. market for Levocarnitine Tablets is approximately $10.0 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
  • "The launch of Levocarnitine Tablets is another example of ANI’s commitment to increasing patient access to affordable, high-quality medicines and aligns with our goal of bringing limited-competition products to market,” 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.

Myelofibrosis Market is Expected to Grow at a CAGR of 7.3% by 2032 | DelveInsight

Retrieved on: 
Monday, December 19, 2022
Thrombocythemia, Chronic leukemia, Physical examination, Bristol Myers Squibb, Fibroblast, Patient, GIST, Vomiting, Multiple myeloma, Bruise, B cell, Bone marrow, Lymphoma, LAS, Abdomen, Roche, Weight loss, Swelling, Bleeding, Anemia, Diagnosis, Transient myeloproliferative disease, XPO1, Abbreviated New Drug Application, Primary myelofibrosis, Novartis, FDA, Degenerative disease, Polycythemia, Geron Corporation, United Kingdom, Fatigue, Ruxolitinib, NDA, Selinexor, GSK, Infection, Nausea, AbbVie, Acute leukemia, MorphoSys, New Drug Application, Bone marrow failure, Symptoms of COVID-19, Abdominal pain, Pharmaceutical industry, Lithium

LAS VEGAS, Dec. 19, 2022 /PRNewswire/ -- DelveInsight's Myelofibrosis Market Insights report includes a comprehensive understanding of current treatment practices, myelofibrosis emerging drugs, market share of individual therapies, and historical, current as well as forecasted myelofibrosis market size from 2019 to 2032, segmented into 7MM [the United States, the EU5 (Germany, France, Italy, Spain, and the United Kingdom), Japan].

Key Points: 
  • The myelofibrosis market is expected to grow at a faster rate due to increased awareness and increase in novel discoveries.
  • The expected launch of potential emerging therapies will boost the myelofibrosis market during the forecast period (2022–2032) in the 7MM.
  • According to the assessment done by DelveInsight, the estimated total myelofibrosis prevalent population in the 7MM was approximately 39.7K in 2021.
  • The myelofibrosis market size is expected to increase owing to the increase in the prevalent population of myelofibrosis patients in the 7MM.

Corcept Therapeutics Settles Patent Litigation with Hikma Pharmaceuticals

Retrieved on: 
Thursday, December 8, 2022
Prostate, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., Microdeletion syndrome, Ovary, Hyperglycemia, Judgement, Liver disease, United States district court, Federal Trade Commission, Food, ALS, FDA, Abbreviated New Drug Application, NASH, Wilms' tumor, Court, United States federal executive departments, DOJ, Prediabetes, Amyotrophic lateral sclerosis, MD, Fatty liver disease, CORT, ANDA, Patent, Weight gain, Patient, Corcept Therapeutics, FTC, Pharmaceutical industry

In connection with the settlement, Corcept has granted Hikma the right to sell a generic version of Korlym in the United States beginning October 1, 2034 or earlier under circumstances customary for settlement agreements of this type.

Key Points: 
  • In connection with the settlement, Corcept has granted Hikma the right to sell a generic version of Korlym in the United States beginning October 1, 2034 or earlier under circumstances customary for settlement agreements of this type.
  • “It is gratifying to put an end to this litigation,” said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.
  • As required by law, Corcept and Hikma will submit the agreement to the United States Federal Trade Commission (FTC) and the United States Department of Justice (DOJ) for review.
  • Similar patent litigation brought by Corcept against Teva Pharmaceuticals USA, Inc. remains pending.

Liquidia Announces Collaboration to Develop a New Infusion Pump for Subcutaneous Delivery of Treprostinil Injection to Treat Pulmonary Arterial Hypertension (PAH)

Retrieved on: 
Monday, December 5, 2022
Degenerative disease, Insulin, Software, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., PAH, Abbreviated New Drug Application, Lung, New York Heart Association Functional Classification, COVID-19, Hypertensive emergency, INSPIRE, Treprostinil, Health, Food, FDA, Safety, Regulation of tobacco by the U.S. Food and Drug Administration, Commercial, Douglas v. U.S. District Court ex rel Talk America, Intellectual property, Patent, Senior, Functional, Coronavirus, Pulmonary hypertension, NYHA, Trial of the century, Environment, Pharmacology, Exercise, District court, ANDA, Patient, Physician, Pump, Court, United Therapeutics, PTAB, NDA, Partnership, Medical device, Pharmaceutical industry, Novartis

Mainbridge will perform all development, validation and testing activities required for the pump and related consumables.

Key Points: 
  • Mainbridge will perform all development, validation and testing activities required for the pump and related consumables.
  • In connection with the execution of the Pump Agreement, Liquidia and Sandoz also agreed to extend their promotion agreement for Treprostinil Injection by another five years until December 31, 2032.
  • Liquidia Technologies has developed YUTREPIA™ (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH).
  • Liquidia PAH provides the commercialization for pharmaceutical products to treat pulmonary disease, such as generic Treprostinil Injection.