ABBREVIATED NEW DRUG APPLICATION

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• USFDA gives a nod to Lupin for smoking cessation drug Chantix

  Varenicline tablets, 0.5 mg, and 1 mg are indicated for use as an aid in smoking cessation treatment. The product will be manufactured at Lupin’s Pithampur facility in India.

  

• Lupin receives US FDA approval for pitavastatin tablets

  Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia; Adults and paediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

  

• Granules India receives USFDA approval for OTC equivalent of Advil Dual Action tablets

  The approved drug is called Acetaminophen and Ibuprofen tablets, with a strength of 250 mg/125 mg, and it can be purchased over the counter (OTC). The USFDA has confirmed that this drug is equivalent to Advil Dual Action with acetaminophen tablets, which is manufactured by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

  

• Lupin receives tentative USFDA approval for Obeticholic acid tablets

  The new Lupin tablets are the generic equivalent of Ocaliva tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc, indicated for primary biliary cholangitis.

  

• Caplin receives US FDA approval for generic Rocuronium Bromide Injection

  The injections are the generic version of Zemuron Bromide Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA Inc, and will be used as an adjunct to general anaesthesia.

  

• Alembic Pharmaceuticals announces US FDA tentative approval for antidepressant tablets

  Brexpiprazole tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for the treatment of schizophrenia. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

  

• Alembic receives final USFDA nod for cancer treatment injections

  The new injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck

  

• Granules gets USFDA's nod for Amphetamine capsules

  Amphetamine is bioequivalent to the reference listed drug product (RLD), Adderall XR extended-release capsules of Takeda Pharmaceuticals. This product will be manufactured at Granules manufacturing facility in Chantilly, Virginia, and is expected to be launched shortly, according to a company statement shared with stock exchanges.

  

• US FDA approves Lupin for generic drugs to treat HIV infection

  Lupin’s Abbreviated New Drug Application (ANDA), Dolutegravir and Rilpivirine tablets gets tentative approval from US FDA.

  

• Lupin receives tentative approval from USFDA for Drospirenone tablets

  Drospirenone tablets, 4 mg are the generic equivalent of Slynd Tablets, 4 mg, of Exeltis USA Inc.

  

• USFDA approves Alembic’s Ketorolac tromethamine injection USP

  Ketorolac Tromethamine is indicated for the short-term (less than five days) management of moderately severe acute pain in adult patients.