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NEWS #PharmaBuzz
29 Oct 2025
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-29-2025-82388.pdf
17 Sep 2025
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-17-2025-5582.pdf
03 Sep 2025
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-3-2025-81425.pdf
01 Aug 2025
// INDPHARMAPOST
https://www.indianpharmapost.com/news/aurobindo-to-acquire-lannett-company-for-rs-2185-cr-17515
11 Dec 2024
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-11-2024-90405.pdf
16 Jun 2023
// BUSINESSWIRE
Drugs in Development
Details:
Through the acquisition of Amphetamine Sulfate, a controlled substance targeting Norepinephrine transporter and Dopamine transporter, the deal aims to advance neuroscience research.
Lead Product(s): Amphetamine Sulfate
Therapeutic Area: Psychiatry/Psychology Brand Name: Evekeo-Generic
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Aurobindo Pharma Limited
Deal Size: $250.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition July 31, 2025
Lead Product(s) : Amphetamine Sulfate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Aurobindo Pharma Limited
Deal Size : $250.0 million
Deal Type : Acquisition
Aurobindo to Acquire Lannett for Rs. 2,185 Cr
Details : Through the acquisition of Amphetamine Sulfate, a controlled substance targeting Norepinephrine transporter and Dopamine transporter, the deal aims to advance neuroscience research.
Product Name : Evekeo-Generic
Product Type : Controlled Substance
Upfront Cash : Undisclosed
July 31, 2025
Details:
Numbrino™ (Cocaine Hydrochloride Nasal Solution) company's branded topical anesthetic product for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
Lead Product(s): Cocaine Hydrochloride
Therapeutic Area: Neurology Brand Name: Numbrino
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 21, 2022
Lead Product(s) : Cocaine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lannett Receives Fda Approval To Manufacture Numbrino® At Seymour Plant
Details : Numbrino™ (Cocaine Hydrochloride Nasal Solution) company's branded topical anesthetic product for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
Product Name : Numbrino
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 21, 2022
Details:
Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine (Glaricon) are approximately $10 billion annually, according to IQVIA, although manufacturer reported sales are less.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Glaricon
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: HEC Group
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 31, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : HEC Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine (Glaricon) are approximately $10 billion annually, according to IQVIA, although manufacturer re...
Product Name : Glaricon
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
August 31, 2022
Details:
Under terms of the amendment, Societal will now receive improved overall economics, including a 10% increase in the profit share component of revenue from Verapamil PM product sales, as well as immediate and scheduled increases in manufacturing prices.
Lead Product(s): Verapamil Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Verelan PM
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Societal CDMO
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 12, 2022
Lead Product(s) : Verapamil Hydrochloride
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Recipient : Societal CDMO
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under terms of the amendment, Societal will now receive improved overall economics, including a 10% increase in the profit share component of revenue from Verapamil PM product sales, as well as immediate and scheduled increases in manufacturing prices.
Product Name : Verelan PM
Product Type : Miscellaneous
Upfront Cash : Undisclosed
July 12, 2022
Details:
The first study, which the FDA reviewed, suggested that the HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Glaricon
Study Phase: Phase IProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 29, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lannett Initiates Pivotal Clinical Trial for Biosimilar Insulin Glargine
Details : The first study, which the FDA reviewed, suggested that the HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.
Product Name : Glaricon
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
March 29, 2022
Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus, Type 1.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Peptide, Unconjugated
Sponsor: Parexel | Farmovs
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 21, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Parexel | Farmovs
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus, Type 1.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
February 21, 2022
Details:
Lannett Company has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva® Handihaler® (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd.
Lead Product(s): Tiotropium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Respirent Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 29, 2021
Lead Product(s) : Tiotropium Bromide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Recipient : Respirent Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
LANNETT Expands Respiratory Pipeline, Signs Exclusive Commercialization
Details : Lannett Company has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva® Handihaler® (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
July 29, 2021
Details:
Respirent Pharmaceuticals has summited an Abbreviated New Drug Application for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the U.S. FDA. The product is the generic equivalent of ADVAIR DISKUS of GlaxoSmithKline.
Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Flovent Diskus
Study Phase: Phase IVProduct Type: Steroid
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 01, 2021
Lead Product(s) : Fluticasone Propionate,Salmeterol Xinafoate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lannett Submits ANDA For Generic ADVAIR DISKUS®
Details : Respirent Pharmaceuticals has summited an Abbreviated New Drug Application for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the U.S. FDA. The product is the generic equivalent of ADVAIR DISKUS of Glax...
Product Name : Flovent Diskus
Product Type : Steroid
Upfront Cash : Inapplicable
April 01, 2021
Details:
The biosimilar insulin aspart is currently in development and Lannett will help manage the remaining clinical and regulatory steps specific for a U.S. Food and Drug Administration (FDA) approval to market the product.
Lead Product(s): Insulin aspart
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Hormone
Recipient: HEC Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 09, 2021
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Recipient : HEC Group
Deal Size : Undisclosed
Deal Type : Collaboration
Lannett Expands Strategic Relationship To Include Biosimilar Fast-Acting Insulin
Details : The biosimilar insulin aspart is currently in development and Lannett will help manage the remaining clinical and regulatory steps specific for a U.S. Food and Drug Administration (FDA) approval to market the product.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Undisclosed
February 09, 2021
Details:
Lannett announced that it has entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of Flovent® Diskus® (Fluticasone Propionate Powder Inhaler) of Respirent Pharmaceuticals.
Lead Product(s): Fluticasone Propionate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Flovent Diskus
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Respirent Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 17, 2020
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Respirent Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
Details : Lannett announced that it has entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of Flovent® Diskus® (Fluticasone Propionate Powder Inhaler) of Respirent Pharmaceuticals.
Product Name : Flovent Diskus
Product Type : Steroid
Upfront Cash : Undisclosed
August 17, 2020
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