Alembic gets FDA OK for 2 generics

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Alembic gets FDA OK for 2 generics

By Sandra Levy - 05/19/2020

Alembic Pharmaceuticals has received Food and Drug Administration approval for two generics. The agency approved the company's generic Vibra-Tabs (doxycycline hyclate tablets), as well as its Clobex shampoo (clobetasol propionate shampoo) generic through its Aleor Dermaceuticals joint venture. 

Alembic's clobetasol propionate shampoo will be available in 0.05% dosage strength. It is indicated to treat moderate to severe forms of scalp psoriasis in patients 18 years old and older. Clobetasol propionate shampoo, 0.05%, had an estimated market value of $28 million for the 12 months ended December 2019, according to IQVIA.

Alembic’s doxycycline hyclate tablets in a dosage strength of 100 mg. The product is indicated to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria; in acute intestinal amebiasis; in severe acne; and for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains.

Doxycycline hyclate tablets, 100 mg, had a market value of roughly $53 million for the 12 months ended December 2019, according to IQVIA.

 

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