Amneal Introduces Isotretinoin Capsules, USP

Amneal Pharmaceuticals has launched isotretinoin capsules, USP, an AB-rated generic for Accutane® in 10 mg, 20 mg, 30 mg and 40 mg strengths. The product is available in cartons containing 3 blister packs of 10 capsules each.

Amneal's generic received FDA approval under a Risk Evaluation and Mitigation Strategy (REMS) known as the iPledge program.

Annual U.S. sales of isotretinoin capsules were $250 million, according to December 2017 IQVIA™ market data. Isotretinoin capsules began shipping today.

About Amneal

Amneal Pharmaceuticals LLC, a privately-held company headquartered in Bridgewater, New Jersey, is one of the largest and the fastest growing generics pharmaceutical manufacturers in the United States. Founded in 2002, Amneal now has more than 5,000 employees in North America, Asia and Europe, working together to bring high quality affordable medicines to patients worldwide. Amneal has significantly expanded its portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas.

Amneal Pharmaceuticals LLC and Impax Laboratories, Inc. (NASDAQ: IPXL) announced on October 17, 2017 that they have entered into a definitive business combination agreement with the resulting combined company expected to create the 5th largest generics business (by gross revenue) in the United States. The transaction is expected to close in the first half of 2018.

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Product photo is available upon request.