Alembic gets USFDA nod for doxycycline hyclate tablets

Alembic Pharmaceuticals on Thursday said it has received final approval from US health regulator for its generic doxycycline hyclate tablets used for the treatment of adult periodontitis. The approval by the US Food and Drug Administration (USFDA) is for abbreviated new drug application (ANDA) doxycycline hyclate tablets of 20 mg strength, the company said in a regulatory filing.

The approved ANDA is therapeutically equivalent to the reference listed drug product Periostat Tablets, 20 mg of Galderma Laboratories, LP, it added. 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, the company said.

Citing IQVIA data, Alembic said doxycycline hyclate tablets 20 mg have an estimated market size of USD 7 million for the 12-month period ending December 2019. The company has a cumulative total of 119 ANDA approvals (107 final approvals and 12 tentative approvals) from the USFDA, it said..