The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets of strengths 20 mg and 40 mg, Granules India said in a regulatory filing.
The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Esomeprazole Magnesium delayed-release capsules of strengths 20 mg and 40 mg, Granules India said in a regulatory filing.
New Delhi, Dec 30: Granules India Ltd on Thursday said it has received approval from the US health regulator for its generic Amphetamine mixed salts indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. The approval granted by the US Food and Drug Administration (USFDA) to Granules Pharmaceuticals, Inc (GPI), a wholly-owned arm, is for the abbreviated new drug application (ANDA) of amphetamine mixed salts of strengths 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg immediate release […]
NEW DELHI, Dec 28: Pharmaceuticals firm Granules India Ltd on Tuesday said it has received approval from the US health regulator for its generic Prazosin Hydrochloride capsules used for the treatment of high blood pressure. The US Food & Drug Administration (USFDA) granted approval to the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI) — a wholly owned foreign subsidiary of the company — for Prazosin Hydrochloride capsules, of strengths 1mg, 2mg and 5mg, Granules India Limited […]
USFDA approves Granules drug for migraine
By IANS |
Published on
Wed, Feb 24 2021 20:36 IST |
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Migraine Attack (Photo: Pixabay). Image Source: IANS News
Hyderabad, Feb 24 : Granules India Ltd on Wednesday announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for the treatment of migraine.
It is bioequivalent to the Reference Listed Drug (RLD) product, Excedrin Migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare.
The product would be manufactured at Granules India s Hyderabad facility and is expected to be launched shortly. We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine tablets, emphasising our focus on building a sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from filing. With this, we have receiv