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MedMonitor

An up-to-date timeline of FDA approvals that could impact workers' comp
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Qulipta (atogepant) tablets for oral use

Approval Date: Sep 2021

Note: New Product

Indicated for the preventive treatment of episodic migraine

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Jentadueto® (linagliptin and metformin hydrochloride) tablets

Approval Date: Aug 2021

Note: First-Time Generic

Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes

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Tradjenta® (linagliptin) tablets

Approval Date: Aug 2021

Note: First-Time Generic

Adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes

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Xeljanz® XR (tofacitnib) extended-release tablets

Approval Date: Aug 2021

Note: First-Time Generic

This is the first time a generic has been approved for Xeljanz XR – other formulations of Xeljanz have received generic approvals, but this new generic approval applies to the extended-release formulation. For the treatment of moderate-to-severe active rheumatoid arthritis, active psoriatic arthritis, or ulcerative colitis

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Duexis® (ibuprofen and famotidine) tablets

Approval Date: Aug 2021

Note: First-Time Generic

This is the first time a generic has been approved for Duexis. For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, and to decrease the risk of developing upper gastrointestinal ulcers

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Belbuca® (buprenorphine) buccal film

Approval Date: Aug 2021

Note: First-Time Generic

This is the first time a generic has been approved for Belbuca. For the management of pain severe enough to require daily, around the clock, long-term opioid treatment for which alternative treatment options are inadequate

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Semglee® (insulin glargine-yfgn) injection for subcutaneous use

Approval Date: Jul 2021

Note: New Product

This is the first time a generic has been approved for Semglee. For the treatment of Type 1 and Type 2 diabetes, this drug is both a biosimilar to, and interchangeable with Lantus (insulin glargine)

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WEGOVY (SEMAGLUTIDE) INJECTION

Approval Date: Jun 2021

Note: New Product

For chronic weight management with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) for use in addition to a reduced calorie diet and increased physical activity

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ADUHELM (ADUCANUMAB-AVWA) INJECTION

Approval Date: Jun 2021

Note: New Product

A first-of-its-kind, biologic treatment for Alzheimer’s disease. This drug is the first new Alzheimer’s drug since 2003

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Xeljanz® (tofacitnib) tablets

Approval Date: Jun 2021

Note: First-Time Generic

This is the first time a generic has been approved for Xeljanz. For the treatment of moderate-to-severe active rheumatoid arthritis, and psoriatic arthritis

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