Strides Arcolab announced that it received ANDA approval for Labetalol Hydrochloride or HCI injection of USP 100mg/20ml and 200mg/40 ml strengths. This is expected to be launched shortly.
Labetalol is the third product launched by the company in partnership with Sagent Pharmaceuticals. Under the partnership, both the companies are jointly developing, supplying and marketing more than 25 injectable products for the U.S market.
Labetalol HCI injection is contraindicated in bronchial asthma, overt cardiac failure, greater than first degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypo-tension, and in patients suffering from hypersensitivity to any component of the product.
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