India-based Lupin Limited said that it has obtained tentative approval for its abbreviated new drug application (ANDA) of Doxycycline Capsules, 40 mg from the US Food and Drug Administration (FDA). Doxycycline Capsules, 40 mg is the generic version of Oracea Capsules, 40 mg, of Galderma Laboratories. Oracea, which is a tetracycline class medicine, is used […]
Zydus Lifesciences (previously called Cadila Healthcare) has secured final approval for antiparasitic ointment Ivermectin Cream, 1% from the US Food and Drug Administration (FDA). Ivermectin Cream, 1% is the generic of Soolantra, which is used for treating inflammatory lesions of rosacea. Zydus Lifesciences will manufacture Ivermectin Cream at its topical manufacturing facility in Ahmedabad, India. […]
Alembic Pharmaceuticals said that its joint venture – Aleor Dermaceuticals has secured tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Metronidazole Gel USP, 1 %. According to the Indian pharma company, the approved ANDA is equivalent therapeutically to the reference listed drug product (RLD) – […]