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Boca Pharmacal receives FDA approval for Methimazole tablets

Boca Pharmacal has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Methimazole tablets USP, 5mg and 10mg, the generic version of King Pharmaceuticals' Tapazole Methimazole tablets, indicated to treat hyperthyroidism.

Boca Pharmacal CEO Robert Edwards said this is the company’s first approval this year and it is expecting a second before the end of the first quarter.

"As our pipeline continues to mature and we come to the end of our largest development cycle, Boca expects to have multiple approvals this year," Edwards said.

Boca Pharmacal was founded in 1988 and has a broad reach and a reliable vertical structure that allows them to develop products that include tablets and capsules, semi-solids, solutions, and suspensions.