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Zydus Cadila gets 2 FDA nods, 1 tentative

BY DSN STAFF

Zydus Cadila has received the green light from the Food and Drug Administration for azithromycin for oral suspension in 100 mg/5 mL and 200 mg/5 mL dosage strengths.

Azithromycin is a macrolide antibiotic that fights bacteria. The drug is used to treat such bacterial infections as respiratory infections, skin infections, ear infections and sexually transmitted diseases. The drug will be manufactured at the group’s formulations manufacturing facility at Baddi in India.

In a separate development, Zydus Cadila received tentative approval from the FDA for a generic version of Levitra (vardenafil) hydrochloride tablets in 2.5-mg, 5-mg, 10-mg and 20-mg dosage strengths. The drug is an erectile dysfunction agent that works by blocking a certain enzyme (phosphodiesterase-PDE5) used to treat erectile dysfunction, or impotence.

Vardenafil will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

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