RTT,
Muscarinic antagonists,
Phenols,
Tolterodine,
Urinary incontinence,
Overactive bladder,
Urinary bladder,
Medicine,
Medical specialties,
Organ systems,
Treatments for overactive bladder BAUDETTE, Minn., Jan. 24, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Tolterodine Extended-Release Capsules, 2 mg and 4 mg.
Key Points:
- BAUDETTE, Minn., Jan. 24, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Tolterodine Extended-Release Capsules, 2 mg and 4 mg.
- The launch of Tolterodine ER capsules expands our commercial generic portfolio to 48 drugs."
- Tolterodine Tartrate Extended-Release Capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
- ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.
Retrieved on:
Thursday, January 16, 2020
Chemistry,
Medicine,
Physical sciences,
Kidney diseases,
RTT,
Acute pain,
Kidney stone disease,
Calculus,
Calcium in biology,
Uric acid,
Citric acid,
Oxalate BAUDETTE, Minn., Jan. 16, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Potassium Citrate Extended-Release Tablets USP, 10 mEq and 15 mEq.
Key Points:
- BAUDETTE, Minn., Jan. 16, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Potassium Citrate Extended-Release Tablets USP, 10 mEq and 15 mEq.
- Arthur S. Przybyl, ANI's President and CEO stated, "We are excited to receive FDA approval for this extended release drug that was successfully developed by ANI's internal formulation group.
- Potassium Citrate Extended-Release Tablets USP are indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones.
- ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.
Retrieved on:
Tuesday, January 14, 2020
Psychiatry,
Chemical compounds,
Psychoactive drugs,
Mood stabilizers,
Atypical antipsychotics,
Piperidines,
Lactams,
Paliperidone,
Antipsychotic,
Schizoaffective disorder,
Alkermes BAUDETTE, Minn., Jan. 14, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg and 9 mg.
Key Points:
- BAUDETTE, Minn., Jan. 14, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Paliperidone Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg and 9 mg.
- The product was developed by Inventia Healthcare Limited as part of a two drug development, manufacturing and commercialization partnership.The launch expands our commercial generic portfolio to 47 drugs."
- Paliperidone Extended-Release Tablets is an atypical antipsychotic agent indicated for the treatment of schizophrenia, the treatment of schizoaffective disorder as monotherapy, and as an adjunct to mood stabilizers and/or antidepressants.
- ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.
Retrieved on:
Wednesday, December 18, 2019
Cardiac arrhythmia,
RTT,
Circulatory system,
Cardiovascular system,
Antiarrhythmic agents,
Cardiology,
Medical emergencies,
Potassium channel blockers,
Bretylium,
Ventricular tachycardia,
Tachycardia,
Ventricular fibrillation BAUDETTE, Minn., Dec. 18, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Bretylium Tosylate Injection USP, 50 mg/mL.
Key Points:
- BAUDETTE, Minn., Dec. 18, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Bretylium Tosylate Injection USP, 50 mg/mL.
- Bretylium Tosylate is a class III antiarrhythmic medication approved for the treatment of ventricular fibrillation and life-threatening ventricular arrhythmias such as ventricular tachycardia.
- Prior to its discontinuation, Bretylium Tosylate was commonly stocked as a standard drug on crash carts.
- ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.
Retrieved on:
Tuesday, November 26, 2019
BAUDETTE, Minn., Nov. 26, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will present on December 3, 2019 at the Evercore ISI HealthCONx Conference in Boston, Massachusetts.Arthur Przybyl, President and CEO, Robert Schrepfer, Senior Vice President Business Development & Specialty Sales, and Mark Ginski, Vice President Cortrophin Product Development, will present at 10:15 AM ET on Tuesday, December 3, 2019.
Key Points:
- BAUDETTE, Minn., Nov. 26, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) will present on December 3, 2019 at the Evercore ISI HealthCONx Conference in Boston, Massachusetts.Arthur Przybyl, President and CEO, Robert Schrepfer, Senior Vice President Business Development & Specialty Sales, and Mark Ginski, Vice President Cortrophin Product Development, will present at 10:15 AM ET on Tuesday, December 3, 2019.
- The presentation will be webcast live at http://wsw.com/webcast/evercore4/anip/ .The live webcast will be archived and available through the prior link for 90 days following the presentation.
- ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.
- The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products.
Retrieved on:
Wednesday, November 6, 2019
ANI has completed manufacturing for three registration stability batches and expects to complete API process validation in early fourth quarter of 2019.
Key Points:
- ANI has completed manufacturing for three registration stability batches and expects to complete API process validation in early fourth quarter of 2019.
- ANI has completed manufacturing for three registration stability batches and expects to complete drug product process validation in fourth quarter of 2019 using commercial scale API.
- The results indicate that ANI's Cortrophin Gel (80 units/mL) is effective for its intended use.
- ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals.
Retrieved on:
Thursday, October 31, 2019
RTT,
Cardiac arrhythmia,
Antiarrhythmic agents,
Circulatory system,
Cardiovascular system,
Cardiology,
Medical emergencies,
Potassium channel blockers,
Bretylium,
Ventricular tachycardia,
Heart arrhythmia,
Tachycardia Prior to its discontinuation, Bretylium Tosylate was commonly stocked as a standard drug on crash carts.
Key Points:
- Prior to its discontinuation, Bretylium Tosylate was commonly stocked as a standard drug on crash carts.
- ANI estimates that there are approximately 180,000 crash carts in the U.S. and will recommend at least two vials of Bretylium Tosylate per crash cart.
- Bretylium Tosylate Injection, USP is indicated in the prophylaxis and therapy of ventricular fibrillation.
- Bretylium Tosylate Injection, USP is also indicated in the treatment of life-threatening ventricular arrhythmias, such as ventricular tachycardia that have failed to respond to adequate dose of a first-line antiarrhythmic agent, such as lidocaine.
Retrieved on:
Wednesday, October 30, 2019
BAUDETTE, Minn., Oct. 30, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced today that the Company plans to release its third quarter and year-to-date 2019 financial results on Wednesday, November 6, 2019, before the opening of the U.S. financial markets.
Key Points:
- BAUDETTE, Minn., Oct. 30, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced today that the Company plans to release its third quarter and year-to-date 2019 financial results on Wednesday, November 6, 2019, before the opening of the U.S. financial markets.
- Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Wednesday, November 6, 2019.
- The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875.
- ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals.
Retrieved on:
Tuesday, October 29, 2019
ANI Global Sourceis a world-leading specialty CDMO dedicated to supporting late stage development and commercial manufacture of pharmaceutical products.
Key Points:
- ANI Global Sourceis a world-leading specialty CDMO dedicated to supporting late stage development and commercial manufacture of pharmaceutical products.
- Additionally, the company offers unique expertise in manufacture of hormones, potent compounds, and DEA Class II controlled substances.
- ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.
- The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products.
Retrieved on:
Thursday, October 3, 2019
BAUDETTE, Minn., Oct. 3, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the receipt of clinical data on CortrophinGel (80 units/mL) from a study that evaluated the blood-level cortisol response in a 20-person healthy volunteer population.
Key Points:
- BAUDETTE, Minn., Oct. 3, 2019 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the receipt of clinical data on CortrophinGel (80 units/mL) from a study that evaluated the blood-level cortisol response in a 20-person healthy volunteer population.
- The results indicate that ANI's Cortrophin Gel (80 units/mL) is effective for its intended use.
- In addition, the clinical data demonstrate that ANI's modernized Cortrophin Gel (80 units/mL) drug product has a cortisol response profile consistent with that observed in historical scientific literature that evaluated Cortrophin Gel (44 units/mL) drug product manufactured in the 1960s (Brombacher et.
- In conjunction with our positive results in process and product characterization at commercial scale, method development and validation, release of clinical material and viral clearance, I believe this study demonstrates that we have successfully reproduced the Cortrophin Gel drug previously manufactured in the 1990s.
