Abbreviated New Drug Application

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.

Evofem Biosciences Announces Financial Results for the Third Quarter of 2023

Retrieved on:

Tuesday, November 14, 2023

SAN DIEGO, Nov. 14, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) today announced financial results for the third quarter and nine months ended September 30, 2023. Highlights include:

Key Points:

— Reduced loss from operations by 81% vs. Q3 2022 —
SAN DIEGO, Nov. 14, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) today announced financial results for the third quarter and nine months ended September 30, 2023.
Highlights include:
$5.1 million in net product sales of Phexxi® (lactic acid, citric acid and potassium bitartrate) for the third quarter of 2023 and $13.4 million year-to-date 2023.
Third quarter total operating expenses were $8.7 million for 2023, a decrease of 65% as compared with the same period last year.
Narrowed loss from operations by 81% in the third quarter of 2023 as compared with the prior year quarter.

Neurocrine Biosciences Announces Settlement of INGREZZA Abbreviated New Drug Application (ANDA) Litigation

Retrieved on:

Monday, November 13, 2023

Abbreviated New Drug Application, Patent, SAN, Neurocrine Biosciences, Neurocrine, Anders, Generic drug, Pharmaceutical industry

SAN DIEGO, Nov. 13, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced that is has resolved all patent litigation related to lawsuits resulting from Abbreviated New Drug Applications (ANDAs) brought by companies seeking approval to market a generic version of INGREZZA® (valbenazine) prior to the expiration of applicable Neurocrine patents.

Key Points:

SAN DIEGO, Nov. 13, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced that is has resolved all patent litigation related to lawsuits resulting from Abbreviated New Drug Applications (ANDAs) brought by companies seeking approval to market a generic version of INGREZZA® (valbenazine) prior to the expiration of applicable Neurocrine patents.
As part of the resolution of these lawsuits, four companies have the right to sell generic versions of INGREZZA in the United States beginning March 1, 2038, or earlier under certain customary circumstances.
"These settlements reinforce our belief in the strength of the INGREZZA intellectual property estate and provide clarity regarding INGREZZA exclusivity.
As an innovation-driven biopharmaceutical company, we will continue to develop treatments for under-addressed diseases and rely on a robust patent system to protect that investment in innovation," said Darin Lippoldt, Chief Legal Office of Neurocrine Biosciences.

Journey Medical Corporation Announces Data from Bioavailability Study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg)

Retrieved on:

Friday, October 20, 2023

FDA, Fasting, Headache, Minocycline, Rosacea, Food, Abbreviated New Drug Application, Conference, Entrepreneurship, Pharmacokinetics, Male, Marketing, Safety, Patient, Generic drug, Pharmaceutical industry

SCOTTSDALE, Ariz., Oct. 20, 2023 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced data from a comparative bioavailability (bridging) study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg). DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd. The data were presented at the 43rd Annual Fall Clinical Dermatology Conference taking place in Las Vegas, NV.

Key Points:

DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd.
The data were presented at the 43rd Annual Fall Clinical Dermatology Conference taking place in Las Vegas, NV.
“The results of this bioavailability study successfully demonstrate that the systemic exposure of minocycline with DFD-29 (40 mg) was significantly lower than that of Solodyn (105 mg),” said Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical.
Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “We continue to be encouraged by the growing body of clinical research evaluating DFD-29.

Evofem Biosciences Announces Preliminary Results for the Third Quarter of 2023

Retrieved on:

Tuesday, October 24, 2023

FDA, Food, Security, Note, Regulation of tobacco by the U.S. Food and Drug Administration, Citric acid, OTCQB, Lactic acid, Lactic acid/citric acid/potassium bitartrate, Growth, Marketing, File, New Drug Application, Fourth, Abbreviated New Drug Application, Fourth Amendment, Constitutional right, Video game, Pharmaceutical industry

SAN DIEGO, Oct. 24, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFMD) ("Evofem") today announced preliminary results for the third quarter of 2023, including sequential growth in net product sales of its hormone-free prescription contraceptive gel, Phexxi® (lactic acid, citric acid and potassium bitartrate) and the positive impact of ongoing cost containment initiatives.

Key Points:

Phexxi net product sales expected to be $5.0 to $5.2 million for the third quarter of 2023.
Selling and marketing expenses were more than 75% lower and total operating expenses were more than 65% lower in the third quarter of 2023 than the third quarter of 2022.
Reduced loss from operations by more than 80% in the third quarter of 2023 as compared to the third quarter of 2022.
The Company expects to report full unaudited results for the three- and nine- months ended September 30, 2023, in mid-November.

Hyloris announces U.S. FDA Approval of Maxigesic® IV

Retrieved on:

Wednesday, October 18, 2023

Analgesic, Abbreviated New Drug Application, Paracetamol, IV, Hikma Pharmaceuticals, Hospital, EUR, New Drug Application, CET, USD, NDA, Brussels Stock Exchange, Pain, Pharmaceutical industry, AFT

The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo.

Key Points:

The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo.
The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates.
Under the terms of the development collaboration agreement between Hyloris and AFT, Hyloris is eligible to receive a share on any product-related revenues, such as license fees, royalties and milestone payments, received by AFT.
Following first U.S. sales, Hyloris will be entitled to a milestone payment of USD 2,1 million.

Evofem Announces Padagis Will Not Seek FDA Approval to Market a Generic Version of Phexxi® Until Evofem's Phexxi Patents Expire

Retrieved on:

Wednesday, September 27, 2023

Abbreviated New Drug Application, Lactic acid, Paragraph, OTCQB, Certification, Orange Book, SAN, Citric acid, ANDA, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Approved Drug Products with Therapeutic Equivalence Evaluations, Generic drug, Lactic acid/citric acid/potassium bitartrate

SAN DIEGO, Sept. 27, 2023 /PRNewswire/ -- Evofem Biosciences, Inc., (OTCQB: EVFM) today announced that Padagis Israel Pharmaceuticals Ltd. (Padagis) has withdrawn the Paragraph IV certification in its previously-submitted Abbreviated New Drug Application (ANDA) for a generic version of Phexxi® (lactic acid, citric acid and potassium bitartrate) and has instead converted to a Paragraph III certification. With this pivot to Paragraph III certification, rather than challenging the Phexxi patents and seeking approval of the ANDA prior to expiration of any of those patents, Padagis is instead now asking the U.S. Food and Drug Administration (FDA) to wait until after all the Phexxi patents expire before issuing final approval of the ANDA. The latest-expiring Phexxi patents do not expire until 2033.

Key Points:

With this pivot to Paragraph III certification, rather than challenging the Phexxi patents and seeking approval of the ANDA prior to expiration of any of those patents, Padagis is instead now asking the U.S. Food and Drug Administration (FDA) to wait until after all the Phexxi patents expire before issuing final approval of the ANDA.
Padagis previously submitted its ANDA in April 2023 requesting permission to manufacture and market a generic version of Phexxi.
That ANDA contained a Paragraph IV certification, in response to which Evofem initiated patent infringement litigation against Padagis.
' All four patents would need to expire or be deemed invalid or not infringed before a generic version of Phexxi could be marketed.

PharmaTher Announces FDA Acceptance, As a Priority Original Abbreviated New Drug Application, for KETARX™ (Ketamine)

Retrieved on:

Wednesday, September 27, 2023

Pain disorder, Abbreviated New Drug Application, Partnership, CSE, Depression, Anxiety, Pain, Food and Drug Administration Safety and Innovation Act, Ketamine, Hospital, ANDA, Suicidal ideation, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mental health, Therapy, Food, Pharmaceutical industry

TORONTO, Sept. 27, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (“FDA”) has accepted the Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”). The FDA assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date for this priority original ANDA of April 29, 2024. The Company anticipates the commercial launch of KETARX™ in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine.

Key Points:

The FDA assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date for this priority original ANDA of April 29, 2024.
The Company anticipates the commercial launch of KETARX™ in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine.
PharmaTher’s priority is to commercialize KETARX™ in the U.S. through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company.
The Company expects to market various dosage forms of KETARX™, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.

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

Retrieved on:

Tuesday, September 12, 2023

Abbreviated New Drug Application, ANI, Food and Drug Administration, Tablet, RLD, Estradiol, Patient, Estradiol valerate, ANDA, FDA, Food, Pharmaceutical industry, IQVIA

BAUDETTE, Minn., Sept. 12, 2023 (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 Estradiol Tablets USP.

Key Points:

BAUDETTE, Minn., Sept. 12, 2023 (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 Estradiol Tablets USP.
ANI’s Estradiol Tablets USP are the generic version of the Reference Listed Drug (RLD) Estrace®.
The According to IQVIA, a leading healthcare data and analytics provider, the current annual U.S. market for Estradiol Tablets USP is approximately $40.9 million.
“The approval and launch of Estradiol Tablets, so quickly following our launch last month of Estradiol Gel, exemplifies the ongoing strength of ANI’s Generics portfolio as well as our ongoing commitment in ensuring that patients and providers have access to the high-quality medications they depend on,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.