Alembic Pharmaceuticals receives USFDA approval for Doxycycline Hyclate Tablets

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP, 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Periostat Tablets, 20 mg of Galderma Laboratories, L.P. (Galderma). Doxycycline Hyclate Tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

Doxycycline Hyclate Tablets USP, 20 mg have an estimated market size of US$ 7 million for twelve months ending December 2019 according to IQVIA.

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