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Breckenridge gets FDA nod for 2 generics


Breckenridge has received the Food and Drug Administration’s stamp of approval for two generic drugs.

The first drug approval is for everolimus tablets. The product, which is the generic for Novartis’ Afinitor was developed in collaboration with Natco Pharma.

Afinitor is a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin and adults with progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced or metastatic.

Afinitor and its generics had a market value of $712 million during the 12 months ended December 2020, according to industry data. 

Breckenridge plans to launch everolimus tablets in dosage strengths of 2.5 mg, 5 mg and 7.5 mg during the second quarter of 2021 in a blister card packaging configuration. Breckenridge's launch of the product's 10 mg strength is based on terms that are presently confidential and will be announced at a later date.

Breckenridge also obtained the FDA’s blessing for asenapine sublingual tablets in a 5 mg strength. The product is a generic of AbbVie’s Saphris.

Saphris is used for acute bipolar mania in adults, children and teens ages 10-17, and schizophrenia in adults.

Breckenridge plans to launch the 5 mg strength immediately. Breckenridge previously launched the product's 2.5 mg and 10 mg strengths. This product was developed in collaboration with MSN Laboratories.

Saphris had a market value of $233 million during the 12 months ended December 2020, according to Breckenridge.

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