Amneal Get Generic TobraDex® Approval | Business

Amneal Get Generic TobraDex® Approval | Business


Bridgewater, NJ-(BUSINESSWIRE)-July 19, 2021-

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for a generic version of TobraDex. ® Add another complex ophthalmic product to the generic drug portfolio.

Dexamethasone and Tobramycin Ophthalmic Suspension 0.3% / 0.1% is a generic version of TobraDex® that is indicated for steroid-responsive inflammatory eye diseases for which corticosteroids are indicated and is superficial bacterial eye infection There is a risk of bacterial eye infections.

“Today’s announcement of additional ophthalmic product approvals in our generic portfolio is important. Another proof that our strategy to develop and commercialize complex generics is ongoing.” , Co-Chief Executive Officers Chirag and Chintu Patel said.

According to IQVIA ™, a leading healthcare data and analytics provider, annual US sales of dexamethasone and tobramycin ophthalmic suspensions for the 12 months to May 2021 were approximately $ 118 million.

Important safety information for dexamethasone and tobramycin ophthalmic suspensions 0.3% / 0.1% includes warnings about increased intraocular pressure, cataracts, delayed healing, bacterial infections, viral infections, and fungal infections. increase. Reported side effects include hypersensitivity and local ocular toxicity such as eye pain, pruritus eyelids, edema of the eyelids, and conjunctival hyperemia. See the package insert (PI) for complete prescribing information, including complete safety information...

About Amneil

Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ. (NYSE: AMRX) is a fully integrated pharmaceutical company focused on the development, manufacture and distribution of generic and specialty medicines. With operations in North America, Asia and Europe, the company works primarily to provide high quality medicines to patients in the United States.

Amneal has an extensive portfolio of approximately 250 product families, expanding its portfolio to include complex dosage forms including biosimilars in a wide range of therapeutic areas. We also sell our portfolio of branded medicines through disciplines focused primarily on central nervous system and endocrine disorders.

We also own 65% of AvKARE. AvKARE provides pharmaceutical, medical and surgical products and services primarily to government agencies with a focus primarily on serving the Department of Defense and the Department of Veterans Affairs. AvKARE also focuses on providing 340b certified entity products to provide care and pricing consistency, pharmaceutical and vitamin packagers and wholesale to retail and institutional customers throughout the United States. It is a distributor. For more information, please visit:

Description of future prospects

Certain statements contained in this document regarding matters that are not historical facts may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include management’s intentions, plans, beliefs, expectations, or forward-looking statements. Expected operating results and financial performance. Impact of planned acquisitions and disposals. Our growth strategy. Product development; Regulatory approval; Market position and spending. Words such as “plan,” “expectation,” “will,” “expectation,” and “estimate” are intended to identify statements about estimates and future prospects.

Readers should be careful not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions are found to be inaccurate or reveal known or unknown risks or uncertainties, actual results may differ materially from our expectations and expectations.

Such risks and uncertainties include, but are not limited to: The influence of the COVID-19 pandemic. Impact of global economic conditions; our ability to timely succeed in developing, licensing, acquiring and commercializing new products. Our ability to obtain exclusive sales rights for our products. Competition with brand and generic drug companies in the pharmaceutical industry and the impact of that competition on pricing capabilities. Ability to manage growth, such as through acquisitions. A significant portion of total revenue depends on the sale of a limited number of products. Risk of product liability and other claims against us by consumers and other third parties. Risks associated with changes in the regulatory environment, including US federal and state laws related to the abuse of medical fraud and the privacy and security of medical information, and changes in such laws. Changes to FDA product approval requirements. Risks associated with federal regulation of agreements between manufacturers of branded and generic products. Impact of health care reforms, and changes in coverage and reimbursement levels by government authorities and other third-party payers. Continuing trends in the integration of specific customer groups. Occasionally reliance on a particular license for proprietary technology. We rely on third party suppliers and distributors for the raw materials of our products and certain finished products. Reliance on third party contracts for some of our product offerings. Our ability to identify, acquire or invest in complementary businesses and products on favorable terms. Legal, regulatory, and legislative efforts by brand competitors to stop competition from generics. A considerable amount of resources we spend on research and development. Our ability to generate sufficient cash to cover our significant debt and future debt, and the impact of interest rate fluctuations on such debt. Also, the concentration of ownership of Class A common stock and the fact that it is managed by the Amneal Group. Forward-looking statements contained herein are generally subject to other risks and uncertainties that may be included in our filings with the US Securities and Exchange Commission from time to time. This includes item 1A “Risk Factors” in our latest annual report. Subsequent reports on Form 10-K and Forms 10-Q and 8-K. Investors should be careful not to place undue reliance on such forward-looking statements. These statements are only given as of the date they were created. Forward-looking statements contained in this document are current as of the date of this document and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date of this document. Suppose.

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Contact: Anthony DiMeo

Investor Relations Senior Director

[email protected]

Keywords: United States North America New Jersey

Industry Keywords: Medical Devices FDA Health Surgery Pharmaceutical Biotechnology

Source: Amneal Pharmaceuticals, Inc.

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PUB: 07/19/2021 04:32 PM / DISC: 07/19/2021 04:32 PM

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