Levothyroxine

Food And Drug Administration Grants Two New Label Changes To Tirosint®-Sol (Levothyroxine Sodium) Oral Solution

Retrieved on: 
Monday, December 4, 2023
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The U.S. Food and Drug Administration (FDA) has approved two new changes to the label of Tirosint-SOL (levothyroxine sodium) oral solution, a unique formulation of levothyroxine (LT4) for the treatment of hypothyroidism.

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has approved two new changes to the label of Tirosint-SOL (levothyroxine sodium) oral solution, a unique formulation of levothyroxine (LT4) for the treatment of hypothyroidism.
  • The first regards the use of Tirosint-SOL in the presence of proton pump inhibitor (PPI) therapy.
  • Both label changes help to differentiate Tirosint-SOL from other levothyroxine therapies.
  • Similarly, current labeling for all levothyroxine sodium therapies instructs patients to self-administer the drug once daily, on an empty stomach, one-half to one hour before breakfast.

IBSA Increases Dosage Flexibility of Tirosint® Capsules

Retrieved on: 
Tuesday, April 4, 2023
Doctor of Pharmacy, Pharmacy, IBSA, Therapeutic index, Business, Absorption, Gelatin, Hypothyroidism, Tablet, Capsule, Patient, Physician, Thyroid, Water, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Caregiver, Pharmaceutical industry, Levothyroxine

PARSIPPANY, N.J., April 4, 2023 /PRNewswire/ -- Americans diagnosed with hypothyroidism now have access to greater dosage flexibility for levothyroxine therapy. IBSA Pharma Inc. is introducing three new dosage strengths of Tirosint® (levothyroxine sodium) capsules to treat hypothyroidism.[1] The three new dosing options – 37.5, 44 and 62.5 micrograms – add to Tirosint's existing 12 options and, along with similar doses of Tirosint®-SOL (levothyroxine sodium) oral solution, provide the widest range of doses for any levothyroxine drug approved by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • PARSIPPANY, N.J., April 4, 2023 /PRNewswire/ -- Americans diagnosed with hypothyroidism now have access to greater dosage flexibility for levothyroxine therapy.
  • IBSA Pharma Inc. is introducing three new dosage strengths of Tirosint® (levothyroxine sodium) capsules to treat hypothyroidism.
  • Increased dosage flexibility may also eliminate or reduce the need to change patients' doses.
  • To help provide patients with cost-effective access to Tirosint, IBSA provides copay coupons and other cost saving programs.

IBSA Pharma and Mark Cuban Cost Plus Drug Company Team Up to Make Tirosint More Affordable

Retrieved on: 
Tuesday, March 7, 2023
PBC, Cost Plus Drugs, Physician, Extrapyramidal system, Lactose, Prescription, Sugar, Pharmacy, Patient, Public, Excipient, IBSA, Negotiation, Hypothyroidism, Pharmaceutical industry, Levothyroxine

PARSIPPANY, N.J., March 7, 2023 /PRNewswire/ -- IBSA Pharma announced today that it has entered into an agreement with Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs) to offer Tirosint® (levothyroxine sodium) oral capsules at a low cash price via the Cost Plus Drugs online pharmacy. The agreement is the first of its kind for a branded levothyroxine drug. Levothyroxine is a synthetic hormone used to treat hypothyroidism. It is one of the most widely dispensed prescription medications in the United States with an estimated 116 million prescriptions filled in 2016.¹

Key Points: 
  • PARSIPPANY, N.J., March 7, 2023 /PRNewswire/ -- IBSA Pharma announced today that it has entered into an agreement with Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs) to offer Tirosint® (levothyroxine sodium) oral capsules at a low cash price via the Cost Plus Drugs online pharmacy.
  • Tirosint has money savings options available for patients, their availability in the Cost Plus Drugs program is a first for both companies.
  • Cost Plus Drugs launched its online pharmacy in 2021 and was co-founded by investor-entrepreneur Mark Cuban to reduce the cost of prescription medications.
  • We are delighted to offer Tirosint capsules to patients via Cost Plus Drugs.

MannKind Corporation Reports 2022 Fourth Quarter and Full Year Financial Results

Retrieved on: 
Thursday, February 23, 2023
Sale, Internet, Acquisition, R, Co-promotion, Investment, G&A, Levothyroxine, Professional corporation, UT, Cryptocurrency, Pharmaceutical industry, Inhalable insulin

As of December 31, 2022, $37.9 million of manufacturing revenue associated with Tyvaso DPI remains deferred and will be recognized as commercial product is sold to UT.

Key Points: 
  • As of December 31, 2022, $37.9 million of manufacturing revenue associated with Tyvaso DPI remains deferred and will be recognized as commercial product is sold to UT.
  • R&D expenses for 2022 were $19.7 million compared to $12.3 million for the prior year.
  • Selling expenses for 2022 were $53.8 million compared to $45.5 million for the prior year.
  • MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time.

Xeris Biopharma Announces Plans for a Phase II Dose-Finding Study for Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121) as Replacement Therapy for Hypothyroidism

Retrieved on: 
Thursday, December 15, 2022
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We received very productive feedback from the FDA on our proposed clinical plan for our once weekly subcutaneous levothyroxine and are in the process of clarifying some aspects of the Phase II and Phase III recommendations.

Key Points: 
  • We received very productive feedback from the FDA on our proposed clinical plan for our once weekly subcutaneous levothyroxine and are in the process of clarifying some aspects of the Phase II and Phase III recommendations.
  • We are excited to commence our Phase II dose-finding study of XP-8121 in 2023.
  • In October, Xeris reported positive topline Phase I data of XP-8121.
  • Hypothyroidism, or underactive thyroid, happens when your thyroid gland doesn't make enough thyroid hormones to meet your body's needs.

Xeris Biopharma Announces Positive Topline Phase 1 Clinical Data of Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121); Hosts Conference Call and Webcast

Retrieved on: 
Thursday, October 20, 2022
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The Phase 1 study was a randomized, open-label, crossover study conducted in 60 healthy adults.

Key Points: 
  • The Phase 1 study was a randomized, open-label, crossover study conducted in 60 healthy adults.
  • We have requested a meeting with the FDA and expect feedback by the end of the year.
  • We are very encouraged with the results of the Phase 1 study of XP-8121, our subcutaneous injection of levothyroxine.
  • Xeris will host a conference call and webcast today, Thursday, October 20, 2022, at 8:30 a.m. Eastern Time.

Professional Golfer Aza Muñoz Returns to LPGA Tour with New Solution for Treating Her Hypothyroidism

Retrieved on: 
Wednesday, August 24, 2022
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Professional golfer Azahara (Aza) Muoz will return to the LPGA Tour this fall as a new mom and as the new spokesperson for Tirosint-SOL (levothyroxine sodium) solution .

Key Points: 
  • Professional golfer Azahara (Aza) Muoz will return to the LPGA Tour this fall as a new mom and as the new spokesperson for Tirosint-SOL (levothyroxine sodium) solution .
  • My body ached, and practicing golf was so tough because I was always tired, said Muoz.
  • She tried to treat her condition using conventional thyroid medicine, but she still struggled with the symptoms of hypothyroidism.
  • We wish Aza the best of luck and health as she returns to the Tour!

MannKind Corporation Reports 2022 Second Quarter Financial Results

Retrieved on: 
Tuesday, August 9, 2022
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DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 09, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the second quarter and first half of 2022.

Key Points: 
  • Conference Call to Begin Today at 5:00 p.m. (ET)
    2Q 2022 Commercial Products Net Revenue of $12.7 million; +28% vs. 2Q 2021
    2Q 2022 Collaboration and Services Revenue of $5.9 million; +171% vs. 1Q 2022
    DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 09, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the second quarter and first half of 2022.
  • Research and development expenses for the second quarter of 2022 were $4.9 million compared to $2.3 million for the second quarter of 2021.
  • Selling, general and administrative expenses for the second quarter of 2022 were $26.0 million compared to $20.0 million for the second quarter of 2021.
  • Interest expense on financing liability was $2.4 million for the second quarter of 2022, representing interest incurred on the November 2021 sale and lease-back of our manufacturing facility in Danbury, CT.
    Interest expense on notes for the second quarter of 2022 was $6.6 million compared to $3.2 million for the second quarter of 2021.

MannKind Corporation Reports 2021 Third Quarter Financial Results

Retrieved on: 
Tuesday, November 9, 2021
Mission statement, Call, United Therapeutics, Total revenue, SG, Investment, MannKind Corporation, COVID-19, Research, Clofazimine, Table, Levothyroxine, UT, GLOBE, Small business, GAAP, PPP, Forgiveness, Amphastar Pharmaceuticals, Doctor of Pharmacy, Midcap, Total, Professional corporation, Cryptocurrency, Pharmaceutical industry, Financial services, Security (finance), Bank

WESTLAKE VILLAGE, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter and nine months ended September 30, 2021.

Key Points: 
  • Research and development (R&D) expenses for the third quarter of 2021 were $3.7 million compared to $1.5 million for the third quarter of 2020.
  • Selling, general and administrative (SG&A) expenses for the third quarter of 2021 were $17.2 million compared to $13.9 million for the third quarter of 2020, an increase of $3.3 million, or 24%.
  • Interest expense on debt for the third quarter of 2021 was $2.8 million compared to $2.4 million for the third quarter of 2020.
  • We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.

MannKind Corporation Reports 2021 Second Quarter Financial Results

Retrieved on: 
Wednesday, August 11, 2021
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WESTLAKE VILLAGE, Calif., Aug. 11, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today reported financial results for the quarter and six months ended June 30, 2021.

Key Points: 
  • Collaboration and services revenue for the second quarter of 2021 increased $5.2 million, or 64%, compared to the second quarter of 2020, primarily due to the Companys collaboration with United Therapeutics.
  • Research and development (R&D) expenses for the second quarter of 2021 were $2.3 million compared to $1.5 million for the second quarter of 2020.
  • For the second quarter of 2021, the loss on foreign currency translation for insulin purchase commitments denominated in Euros was $0.9 million compared to $1.9 million for the second quarter of 2020.
  • Interest expense on debt for the second quarter of 2021 was $3.2 million compared to $2.4 million for the second quarter of 2020.